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- 2026-03-18 10:27:55
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- Awareness of multiple sclerosis should increase
- by Jun 03, 2021 06:12am
- Today (26th) is World MS Day. Although the treatment environment has improved significantly with the release of more new drugs for multiple sclerosis compared to the past, early diagnosis is not easy due to the low awareness of the disease. The same is true of overseas situations. In response, the International Association for Multiple Sclerosis (MSIF) has designated the last Wednesday of May every year to raise awareness of the disease. This year's theme is 'Connection'. The goal is to challenge the social obstacles and isolation experienced by multiple sclerosis patients and establish relationships for patients' better lives. Multiple sclerosis is a chronic disease in the central nervous system, including the brain, spinal cord, and optic nerve, and an autoimmune disease caused by the immune system attacking healthy cells and tissues. If myelin, which surrounds and protects nerve fibers in the central nervous system, is damaged, unregulated inflammatory reactions cause wounds in various areas such as the brain and spinal cord, leading to diseases that interfere with nerve transmission. Multiple sclerosis has a wide variety of conditions and symptoms depending on where it occurs. Sensory abnormalities, visual impairment, fatigue, motor impairment, balance abnormalities, bowel and bladder problems, sexual dysfunction, and pain are combined, which are characterized by repeated recurrence and remission. In the early stages of the outbreak, it improves without a disorder after a recurrence, but it is also a rare incurable disease that does not fully improve over time and remains disabled as the recurrence repeats. The incidence of women is more than 50% higher than that of men, and it often occurs in young people aged 20 to 40 who are actively engaged in social activities. The number of patients in the country is about 2,500. Rare diseases have low awareness, making it difficult for patients to suspect multiple sclerosis. Difficulties in diagnosis also make early diagnosis difficult. This is because there is no specific test method to confirm multiple sclerosis so far. The doctor should observe various symptoms, medical history, and image findings that the patient appeals to and then determine the disease clinically. It usually applies McDonald standards. Progressive multiple sclerosis is classified as primary and secondary progressive. Primary progression is slow to manifest, while secondary to continuous recurrence and recovery continue to deteriorate over a long period of time. In general, about 50% of patients with recurrent palliative multiple sclerosis progresses to secondary progression within 10 years, and 90% of patients switch to secondary progression after more than 25 years. There is no cure for multiple sclerosis, but treatment options have increased. In the early 1990s, when there was no cure at all, the prognosis of patients was poor, but in 1993, the first multiple sclerosis drug appeared, and the prognosis of patients began to improve. In addition, the half-life of the injection has been extended significantly. Currently, multiple sclerosis treatment relieves the disease with steroids during the acute period, and in the long run, the disease is managed with interferon-like injections and oral drugs (DMT). It is important to curb recurrence so that it does not develop into a permanent disability. Reimbursement standards are also improving. As a representative example, the reimbursement clause of Aubagio, an oral primary treatment drug, has been expanded since February this year, allowing oral formulation to be used from the beginning of treatment. Aubagio is the first oral drug to be launched in Korea, and has more than 16 years of long-term safety data to date, along with features that inhibit recurrence and maintain immune action. As there are more options to choose from depending on the patient's life pattern and condition and the benefit is improving, it is important to find and manage medications that can be conveniently treated by the patient themselves. However, there are still diagnostic and therapeutic limitations that arise from unclear causes of the outbreak. Experts say that improving awareness of the disease is urgently needed to elicit early diagnosis. Multiple sclerosis should be suspected if sensory disorders and muscle weakness occur over several days in situations where symptoms of multiple sclerosis are nonspecific, but there is no pain in the neck or back. In particular, if vision disorders accompanied by sudden eye pain are accompanied by young people aged 20 to 50, optic neuritis and spinal cord, which can be seen as before multiple sclerosis, can be suspected. "Multiple sclerosis is possible to slow down the progress of the disease and maintain daily life without disability when appropriate treatment is started in the early stages of the outbreak," said Kim Byung-joon, chairman of the Korean Society of Neuroimmunology. Early diagnosis by professional neurologists is a very important disease, and medical and social understanding and interest in multiple sclerosis need to be improved to maintain continuous treatment by selecting appropriate treatments.
- Company
- Tecentriq attempts reimbursement after Keytruda fails
- by Eo, Yun-Ho Jun 02, 2021 06:11am
- ‘Tecentriq’ is attempting what ‘Keytruda’ had failed. Industry sources have said that Roche Korea had submitted an application for the reimbursement of its ‘Tecentriq (atezolizumab),’ as monotherapy in the first-line setting for non-small cell lung cancer (NSCLC) patients whose tumors have a programmed death ligand-1 (PD-L1) expression on at least 50% of tumor cells (TC), or tumor-infiltrating immune cells covering at least 10% of the tumor area. The company received approval for this indication this April. The agenda will be put up for deliberation by the Cancer Drugs Benefit Appraisal Committee of the Health Insurance Review & Assessment Service in July. Accordingly, the possibility is rising for Tecentriq's reimbursement to be discussed together with MSD Korea’s PD-1 inhibitor ‘Keytruda,' which failed to be approved for the 8th time at the meeting held on the 26th last month, at the next Cancer Drugs Benefit Appraisal Committee meeting. The authorities may induce competition among pharmaceutical companies to reduce fiscal spending, however, this would lead to a delay in reimbursement listing. This irony often occurs in the process of listing expensive new drugs or expanding reimbursement in Korea. As drugs are expensive, if pricing competition arises between pharmaceutical companies, the government can take advantage of the net function of the market. Fiscal savings under the National Health Insurance system saved from such competition can create additional opportunities for coverage expansion. However, the issue at hand is its timing. It would be optimal if drugs of the same class are approved at a similar period so that they can apply for reimbursement listing at a similar timeframe, but this is not likely in reality. In general, the period of each company's reimbursement listing application varies by 6 months to even over a year. Of course, factors other than the physical 'application' date also do play a role in the reimbursement delay, but this difference is important because there are patients awaiting the approval. Moreover, most of the drugs in issue are anticancer drugs. Attention is on what the results would be for the 2 anticancer immunotherapies that walked very different journeys that are attempting the long-delayed reimbursement in first-line lung cancer. The NSCLC reimbursement expansion for Keytruda had been discussed since September 2017, and it has already been nearly 4 years. Among the many barriers, the biggest issue was the ‘pharmaceutical company taking the burden of the initial 3 cycles’ worth of administration cost’ requested by the government to companies with immunotherapy agents. Roche, which owned the then-latecomer Tecentriq was the only company to accept the government’s proposal, and 2 types of PD-1 inhibitors – Keytruda and ‘Opdivo (nivolumab)’ were unable to accept the offer.
- Company
- Improved reg. allow price succession of transfer products
- by Chon, Seung-Hyun Jun 02, 2021 06:10am
- Drug price succession in transferred pharmaceutical products has been increasing. As the stepped pricing system is no longer applied to drugs that are relisted due to change of licensees, companies have been actively engaged in the transfer of their products. Some products have seen a twofold increase in their price compared to when the stepped pricing system was applied. According to the Ministry of Health and Welfare (MOHW) on the 30th, Organon Korea’s ‘Ezetrol tab.’ will be listed at a ceiling price of 744 won. Ezetrol (ezetimibe) originally used to be owned by MSD Korea. As the license holder was changed to Organon Korea, a new spin-off of MSD Korea, the drug had to be newly listed on the health insurance benefit list. MSD Korea’s Ezetrol will be removed from the reimbursement list from next month and its license will be transferred to Organon Korea. In January this year, a drug price succession regulation for transferred products was newly added, which allowed Ezetrol to maintain its previous maximum ceiling price of 744 won. In July last year, the drug pricing system was revised to add a stepped-pricing system that reduces the price of drugs that are listed late. The key point of the system was to reduce the price of later entrant generics by 15% when the number of products exceeds 20. In other words, if there are more than 20 drugs listed of the same ingredient, the drug price is set at ‘85% of the drug price of products that does not satisfy the two qualifications’ or ‘85% of the lowest price among the previously listed drugs,’ whichever is lower. Under the system, an unexpected issue arose as the drug products transferred between businesses were being listed at the lowest price among all products in the same category due to the application of the stepped pricing system. In transfers where the license of a pharmaceutical product is handed over to another company, the product needs to undergo a removal and relisting process. Even products that were previously listed are regarded a newly listed product after removal from the benefits list and is inevitably applied the stepped pricing system. The industry had pointed out that it was unreasonable to list transferred products the same as newly listed products, and the MOHW agreed to improve the system. From January, MOHW had made a partial amendment to the ‘Criteria for Decision or Adjustment on Drugs,’ so that in cases ▲where the manufacturer’s position was succeeded; ▲ where the same company switches its license from manufacturing and marketing to import authorization; or ▲ where the company withdraws its license due to business conversion, etc. and receives relicensing for the same product; the product’s price will be calculated at the same ceiling price that was previously set for the removed product. The regulation allows for the succession of the previous drug price in process of removal and relisting the same products in product transfers, etc. 42 ezetimibe products are currently listed in the reimbursement list, and their prices range from 480 won to 746 won. If Organon Korea’s Ezetrol was to be regarded as a newly listed product, its price may not have exceeded 408 won, which is 85% of the lowest listed price of 480 won. However, with the amendment, the company was able to maintain Ezetrol’s price at its previous listing price of 744 won. Recently, the drug price succession is actively being carried out among transferred drug products. In only this month, 4 products succeeded their previous drug price and were newly listed on the reimbursement benefits list. Daewoong Bio’s amlodipine and Valsartan combination ‘V-Forge Tab 10/160mg’ was newly listed at a ceiling price of 1,128 won on the 1st of this month. 1,128 won is the highest price among all products in its category and dose, and is a price 60% higher than the lowest price, which is 699 won. 81 products of the 10/160mg dose Amlodipine and Valsartan combination are currently listed in Korea. Under the stepped pricing system, newly listed products may not exceed a price of 594 won, which is 85% of the lowest price of 699 won among the same products. However, V-Forge Tab 10/160mg was a transferred product from Cosmax Pharma. By entering the market through a transfer, Daewoong Bio was able to be listed at a price that was twice higher than that of newly authorized products. Alvogen Korea’s ‘Maxgrel-A,’ which was newly listed from this month, received a ceiling price of 1,209 won. This is the highest price among the same products. With 35 Maxgrel-A products already listed, the price of a newly listed product in the same class would have had received a price discount through the stepped pricing system. However, Maxgrel-A was able to maintain its highest price by being newly listed through a transfer. If Maxgrel-A was a newly licensed product, its price would not have been able to exceed 732 won, which is 61.4% of the highest listed price. Celltrion Pharm’s ‘Celltrion Neopa,’ and Albogen Korea’s ‘Lutsnal Cap. 0.4mg’ would also have been applied the stepped drug pricing system, receiving a price that is ‘85% of the lowest price’ or ’61.4% of the highest price.’ However, the drugs were able to maintain their previous price as a transfer product.
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- The FDA's final decision on Rolontis remains
- by An, Kyung-Jin Jun 01, 2021 06:11am
- View of Hanmi The FDA's due diligence on the domestic manufacturing facilities of Rolontis, a drug that Hanmi exported technology, has entered the final stage. The final process for obtaining final FDA approval has been completed as scheduled. Hanmi's partner Spectrum is rushing to prepare to enter the U.S. market worth about ₩3 trillion in preparation for FDA approval within this year. According to an industry on the 1st, FDA pre-approval inspection of Hanmi's Pyeongtaek Bio Plant, which produces undiluted liquid of Rolontis (Eflapegrastim), is underway. The schedule, which was scheduled from the end of last month to the beginning of this month, is progressing smoothly. "We cannot reveal the specific schedule," a source at Hanmi said. The FDA's due diligence has been carried out as scheduled. The due diligence of the Pyeongtaek Bio Plant is the final step for Rolontis' FDA sales license. "Rolontis' remaining procedures related to BLA have been completed," said Spectrum Pharmaceuticals, a U.S. partner of Hanmi. In the aftermath of COVID-19 infection, we were forced to proceed with due diligence at the Pyeongtaek plant," he said, stressing several times that final approval is possible once due diligence is completed." Rolontis is up to the FDA's decision. It is predicted that it will be able to obtain FDA's permission as early as this year. "If there was a problem with the clinical data, the FDA would have sent a CRL in October last year after completing the review of Rolontis," said Joe Turgeon, CEO of Spectrum Pharmaceuticals. "I'm confident that the rest of the process was fine. We are looking forward to FDA approval." Rolontis is a bio-new drug that Hanmi Pharmaceutical Co. transferred to Spectrum in Spectrum in 2012. Cancer patients subject to myelosuppressive chemotherapy are administered for treatment or prevention of neutrophilia. It is a family of "G-CSF" (grain globular stimulators) that stimulates granulocytes to increase the number of neutrophils, similar to Amgen's blockbuster drug "Neulasta" (Pegfilgrastim). If "Rolontis" receives FDA's final approval, Hanmi will release its first bio drug to the U.S. market that combines Labscovery platform technology that increases the duration of bio-medicine in the body. Given that Pyeongtaek Bio Plant has passed the FDA's strict due diligence standards, it can also enjoy the achievement of recognizing biopharmaceutical manufacturing technology. It is estimated that long-term G-CSF markets in the U.S. are worth ₩3 trillion. Amgen's "Neulasta" accounts for about 70%, Mylan's "Fulphila" and Coherus' "Udenyca" account for the remaining 30%. Spectrum has been conducting new global clinical trials since March last year, apart from "Rolontis" licensed clinical trials. It is a study that administers Rolontis on the day of myelosuppressive chemotherapy (Docetaxel+Cyclophosphamide). Existing treatments in the G-CSF family are difficult to administer on the same day as anti-cancer drugs, so patients have to be hospitalized or visit the hospital again the next day. Spectrum is conducting a reaction evaluation by administering Rolontis for 30 minutes, 3 hours, and 5 hours after chemotherapy to ease this hassle. Its strategy is to secure differentiation from competitive drugs by maximizing convenience of patients. Spectrum's management team said at a recent conference call, "Patients' enrollment on the same day of Rolontis is going smoothly. We expect to be able to announce research results by the end of this year. It will serve as data that can differentiate itself from competitive drugs after market release." Hanmi did not disclose specific terms of the contract regarding the transfer of Rolontis technology at the time of the initial contract with Spectrum. However, it is possible to estimate the size of the contract through a report submitted by Spectrum to the U.S. securities and exchange commission (SEC). Spectrum agreed that "If Rolontis obtains FDA's final sales license, Spectrum will pay Hanmi $10 million (about ₩1.9 billion) in technical fees." After its release, it pays an additional percentage of royalties each year depending on net sales.
- Company
- 3-way race between ultra-expensive new orphan drugs to start
- by Jun 01, 2021 06:11am
- With Novartis’s gene therapy ‘Zolgensma’ approved, 3 new drugs have been introduced into the Korean spinal muscular atrophy (SMA) market, a market that previously had virtually no treatment available. The introduction of 3 new drugs in just 3 years marked the start of a full 3-way race between the new SMA treatments in Korea. In the U.S. where the race had already started, Spinraza’s share in the market has been decreasing. As to whether the situation would be the same in Korea is gathering attention. The Ministry of Food and Drug Safety (MFDS) has approved Novartis’ ‘Zolgensma (onasemnogene abeparvovec-xioi)’ as the second advanced biological product in Korea. Zolgensma can be used in SMA patients with a double allelic mutation in the SMN1 gene who have been ▲ clinically diagnosed as SMA Type 1 or ▲ has three or fewer copies of the SMN2 gene. Zolgensma’s different mechanism of action works as a strength over to Spinraza or Evrysdi SMA is a serious rare disease in which muscles gradually degenerate as motor nerves are damaged due to a gene defect in the survival motor neuron 1 (SMN1) gene. One out of every 10,000 infants around the world are diagnosed with SMA, and in Korea, around 30 patients (per 300,000 infants) are diagnosed with SMA every year. The severity of SMA is deeply associated with the number of copies of the “backup” SMN2 gene. The SMN2 gene may produce and compensate at most 10% of the SMN protein unable to be produced by SMN1. Patients with Type 1 SMA that have only 1-2 SMN2 copy genes may experience 95% loss of their motor neurons, and 90% of the patients die before reaching age 2. In Korea, there had been no SMA treatment available until 2017. Biogen’s ‘Spinraza’ was the first to be approved in December 2017, opening up a new treatment paradigm. 자료: 각사 Spinraza is an RNA-based treatment. It is an antisense oligonucleotide splicing modulator that promotes protein production by binding to the pre-mRNA sequence of the SMN protein produced by SMN2. After Spinraza, Roche also received approval for its RNA-based treatment, ‘Evrysdi.’ Unlike Spinraza, which is an injection formulation, Evrysdi is an oral formulation and is cheaper. However, this oral drug needs to be taken every day. Evrysdi has not yet been released in the Korean market. Zolgensma’s mechanism of action is completely different from the two drugs that were previously approved. Unlike Spinraza and Evrysdi, which use the “backup” SMN2 gene to increase the production of proteins, Zogensma completely replaces the function of the missing SMN1 gene to produce SMN proteins. When the replacement, made with a recombinant AAV adeno-associated virus (AAV9), is given to an infant by intravenous infusion, it works as an SMN1 gene and produces proteins. It is also called a 'dream cure' as patients can expect to be completely cured with just a single treatment. As a “one-shot treatment,’ the cost of the drug is also ultra-expensive. The cost of a single Zolgensma infusion costs 2.5 billion won. This is 25 times higher than the cost of Spinraza. However, Novartis explains that the cost-effectiveness of Zolgensma is quite high considering that Spinraza or Evrysdi would cost 0.3-0.5 billion won every year. Spinraza’s sales falter and Evrysdi strong in the U.S…. how about Korea? The SMA market in Korea is currently dominated by Spinraza. Based on IQVIA, Spinraza sold 72 billion won in sales last year. However, with the entry of Zolgensma and the yet-to-be-introduced Evrysdi, the market dominion in Korea is expected to change. Changes in the U.S. SMA market that is already in the 3-way race, can be used as a reference to predict the future of the Korean market. In the U.S. Spinraza’s sales have been showing a decline with the introduction of Zolgensma and Evrysdi. After selling 233 million dollars (approx. 257.3 billion Korean won) in Q1 2019, its sales had started falling from Q2 2020. The sales fell to under 200 million dollars in Q3 2020 to record 183 million dollars (approx. 202.1 billion won), then to 149 million dollars (approx. 164.5 billion won) in Q1 last year. This was a 36% decline in sales over the past 2 years. On the other hand, Zolgensma’s sales have shown a similar record every quarter since its introduction, since Zolgensma is a one-shot treatment that does not accumulate patients. After recording 150 million dollars (165.6 billion won) in Q3 2019 when it started to be prescribed in earnest, its sales have stayed steady in the 100 million to 130 million dollar range (143.5 billion won) every quarter. Evrysdi, which was introduced last in the U.S. market, has been relatively rapidly gaining its share compared to the other two competitors. After receiving approval in August 2020, Evrysdi sold 9 million dollars (9.9 billion won) in Q3 of the same year, which increased to 51 million dollars (56.3 billion won) in Q4, then to 87 million dollars (96.1 billion won) in Q1 this year. It may have had the lowest sales record, but its sales growth is the fastest among the three products. Based on the trend, U.S. experts expect Evrysdi to record the highest sales in 2026 based on its low-cost and oral formulation. Of course, the U.S.’s case may not apply 100% to Korea, as the Korean market is most strongly influenced by whether the drug is reimbursed as well as the reimbursement criteria. However, Spinraza’s sole lead in the Korean market is expected to continue for the time being, until reimbursement is approved for Evrysdi and Zolgensma. Also, there is criticism that the current insurance policy structure makes it difficult to accommodate ultra-expensive drugs like Zolgensma. The various clinical trials ongoing with Spinraza are also a variable. Spinraza has been conducting various clinical trials to maintain its lead in the SMA market; one of which is on asymptomatic infants. This study investigates whether administering Spinraza in advance to infants that have been genetically diagnosed with SMA helps to maintain a normal level of motor function in the patients. If Spinraza is approved for the indication to treat infants with confirmed SMN1 gene defect or mutation prior to diagnosis, Spinraza will be available at the very front-end, before any other treatment. In addition, Biogen has started more aggressive trials as well. The Phase IV RESPOND trial studies the benefit of switching to Spinraza in patients who showed a suboptimal clinical response to Zolgensma. Biogen identified cases of some patients who received Zolgensma but were insufficiently treated and found that switching to Spinraza may bring additional benefits to these patients. A long-term follow-up study showed that 4 out of 10 patients that had previously received Zolgensma have switched to Spinraza to continue their treatment.
- Company
- Astellas notified distributors, Betmiga cannot be returned
- by Kim, Jin-Gu Jun 01, 2021 06:11am
- BetmigaConfusion in pharmacies is expected to continue for a while over the lowering of the drug Betmiga (Mirabegron), an irritable bladder treatment. The pharmaceutical industry and the outpatient pharmacies predict that it will take at least a year for the drug price to be finalized. According to the pharmaceutical industry and pharmacies on the 28th, Astellas Pharma Korea Betmiga PR will be lowered from the 1st of next month. This is because Chong Kun Dang and Hanmi Pharmaceutical succeeded in overcoming patents and released generic. The MOHW has announced that it will lower the upper limit of the original Betmiga from June 1 following the release of generic drugs. However, it is highly likely that Betmiga's drug prices will not be reduced. Astellas disobeyed the second trial's ruling, and the case went to the Supreme Court. Astellas lost the second trial of Betmiga's use-and-crystal patent dispute with 11 companies, including Hanmi, on January 22 this year. Astellas filed an appeal with the Supreme Court on March 3. At the same time, it is said that it filed an injunction with the administrative court to suspend the execution of the drug price notice. Since the related case has not yet been finalized, it is a request to postpone administrative disposition until the Supreme Court ruling is made. This is why Astellas notified distributors of "nonreturnable" and "non-settle balance" by saying, "There is no reduction in drug prices in June." In fact, the same thing happened earlier in the patent dispute surrounding Eliquis. BMS, the original company, maintained an insurance upper limit of ₩1,185 per party by dragging the case to the second trial and applying for an execution suspension of drug prices at the same time, even though generic was released after the first trial was lost. When the second trial was lost, the MOHW warned of a drug price cut, but the BMS applied for an execution suspension of the drug price cut as it dragged the case back to the third trial and eventually the insurance upper limit price was maintained. The case was overturned in the third trial and eventually BMS succeeded in delaying the drug reduction until September 2024. It took about two years for the final sentence (April 8, 2021) to be made after the third trial was held in the Eliquis case (May 3, 2019). Considering this, the pharmaceutical industry and pharmacies predict that it will take at least a year to reach a final conclusion on the reduction of Betmiga prices. Unlike the first and second trials, the Supreme Court does not disclose the date of the sentence to the public. This explains that the company's non-returnable measures and the pharmacy's confusion over them will continue for more than a year. However, there is a possibility that the conclusion may be unusually early. The Supreme Court will decide within four months whether to deal with the case in earnest from the second trial. This is called the discontinuity of trials period, and if the Supreme Court judges that the hearing is unnecessary, the second trial will be finalized before October. "Astellas submitted a statement of grounds of the final civil application," a pharmaceutical industry source said. "We expect a new claim to be made in the Supreme Court, which is different from the second trial," he said. "We believe that the possibility of disccontinuity of trials is low at the moment." For Bayer's new oral anticoagulant Xarelto (Rivaroxaban), the situation is different from that of Betmiga. Bayer is also said to have applied for suspension of execution in the government's disposition to lower drug prices because the lawsuit has not been completed. However, Bayer was defeated in the Supreme Court in December last year. The Supreme Court dismissed Bayer's appeal and sent it back to the Patent Court. Xarelto's prices are likely to remain until the Patent Court has reached the conclusion of the remand trial. In general, the period of judgment is shorter than that of the Supreme Court for destruction and repatriation. This means that the chaos in the pharmacy disappears more than in the case of Betmiga.
- Company
- Beovu can be prescribed at general hospitals
- by Eo, Yun-Ho Jun 01, 2021 06:11am
- AMD treatment Beovu became available in general hospitals with insurance coverage. According to related industries, Novartis Korea's Beovu (Brolucizumab), which has been registered since April, passed drug committees of more than 30 medical institutions including Seoul National University Hospital and Sinchon Severance Hospital. Wet AMD treatment Beovu, in combination with VEGF-A, is a mechanism that inhibits neovascular expression and retinal effusion, administered once a month for the first three months and once every three months. Beovu's efficacy has been demonstrated through two three-phase clinical trials HAWK and HARRIER studies compared to Eylea (Afribercept). Clinical studies of 1,817 patients with macular degeneration related to the age of 50 and older demonstrated noninferiority compared to controls at 1 year (48 weeks) in BCVA (Best-Corrected Visual Acidity) changes, the primary evaluation index. Beovu also demonstrated that the proportion of patients with improved maximum corrective vision (BCVA), which is a secondary evaluation index, by more than 15 letters, was also non-equivalent compared to the control group at week 48. (HAWK study: 34% Beovu group, 25% Eylea group; HARRIER study: 29% Beovu group, 30% Aflibercept group) Furthermore, patients with intra-retinal fluid (IRF)/sub-retinal fluid (SRF) were also significantly lower in the Beovu group, showing superior improvement over controls. Kang Se-woong, an ophthalmologist at Samsung Medical Center, said, "AMD is a disease that can be blind within two years without proper treatment and requires active and effective treatment from the beginning. "Beovu, which is effective not only in improving vision but also in improving the retina, which causes direct degeneration of the macula, will be covered by insurance benefits and will be able to provide patients with effective treatment options." "In particular, as Beovu allows us to maintain a longer, three-month treatment interval than conventional treatment, it is expected that the burden of treatment and the possibility of discontinuation of treatment will be reduced in AMD, where continuous treatment is important," he added. AMD, one of the top three causes of blindness in the elderly population aged 65 and older, is a disease in which vision is degraded due to the metamorphosis of the macular region in charge of vision. Macular degeneration is caused by structural changes and damage to the retina and macula by leaking effluent or blood from abnormally produced blood vessels (new blood vessels). As it is a disease that causes vision loss and blindness, the main treatment goal of Neovascular (Wet) Age-Related Macular Degeneration is focused on improving vision, and anatomical changes should also be considered for effective treatment.
- Company
- Pacenra(Fasenra) can be prescribed at the general hospitals
- by Eo, Yun-Ho May 31, 2021 06:02am
- The severe asthma treatment "Pacenra" is available at general hospitals. According to related industries, Pacenra (or Fasenra, Benralizumab) of Astra Zeneca Korea has passed drug committee (DC) of medical institutions such as Samsung Medical Center, Seoul National University Hospital, Seoul National University Bundang Hospital , Ajou University Hospital, and Wonju Severance Christain Hospital. Pacenra is approved for use as an additional treatment in adult patients with severe anaerobic asthma if it is not properly controlled by conventional treatment, and is then administered once every four weeks for the first three months. One of the reason for asthma management is to reduce the risk of asthma deterioration. Pacenra is an anti-eosinophil, humanised afucosylated, monoclonal antibody (IgG1, kappa). It binds to the alpha subunit of the human interleukin-5 receptor (IL-5Rα) with high affinity and specificity. The IL-5 receptor is specifically expressed on the surface of eosinophils and basophils. The absence of fucose in the Fc domain of benralizumab results in high affinity for FcɣRIII receptors on immune effectors cells such as natural killer (NK) cells. This leads to apoptosis of eosinophils and basophils through enhanced antibody-dependent cell-mediated cytotoxicity (ADCC), which reduces eosinophilic inflammation. According to the SIROCCO study of 1,205 patients with severe asthma worldwide, including 122 Korean patients, the annual asthma exacerbation rate compared to placebo was reduced to 45% in once-four weeks and 51% in once-eight weeks. In addition, another clinical CALIMA study confirmed that the annual asthma exacerbation rate compared to placebo decreased by 36% in the once-in-a-week group and 28% in the once-in-eight-week group, significantly reducing the annual asthma exacerbation rate in the placebo group. In both studies, the change in FEV1 (1-second forcing capability) compared to baseline was measured, and consistent improvement over placebo was shown. In order to evaluate the long-term safety and efficacy of Pasenra in patients with severe anacid, there was no significant difference compared to placebo in the SIROCCO study and BORA study, a 56-week safety assessment extension study of 1926 patients participating in CALIMA study. Asthma, meanwhile, is associated with an unexpectedly high mortality rate. The death rate of hospitalized patients due to asthma is about one-third, and the cost of asthma-related patients requiring emergency treatment or hospitalization accounts for more than 80% of the total asthma-related costs. In particular, eosinophilic inflamination is present in 50% of asthma patients, which can cause poor lung function, worsening asthma, and increased exacerbation rates. Despite proper ICS therapy, patients with eosinophilic inflamination asthma with high levels of eosinophil are often not managed by conventional therapy such as ICS-LABA therapy, which is life-threatening due to pain caused by symptoms and frequent deterioration of diseases.
- Company
- Sales of Gaviscon and Strepsil continue to be sluggish
- by Kim, Jin-Gu May 31, 2021 06:01am
- Gaviscon & StrepsilsSales of Gaviscon and Strepsils have been sluggish for five years since Reckitt's boycott. It is shown that sales of two products decreased by 46% and 74% respectively in first quarter compared to before boycotting. Competitive items are found to benefit from the long-term sluggishness of the two products. According to IQVIA, a pharmaceutical market research company, Strepsil's sales in first quarter of last year were ₩600 million. The figure is down 74% from ₩2.2 billion in the first quarter of 2016, just before the boycott of the entire Reckitt product began in earnest. The boycott of Reckitt products began in earnest after the second quarter of 2016. At that time, the humidifier disinfectant incident caused a lot of controversy, and as public opinion deteriorated sharply, it spread to a boycott of the entire product. The company changed its name from Oxy Reckitt to Reckitt, but it was not enough. Strepsils was ranked first in the sore throat treatment market with quarterly sales of about ₩2 billion before the boycott. However, since the boycott began in earnest, it has only generated ₩600 million to ₩1.2 billion in sales so far. Competing products are enjoying reflective benefits due to Strepsil's sluggishness. The representative product is Boryung's Younggaksan. Immediately after the boycott, it beat Strepsils and became the No. 1 item in the market. Its quarterly sales are about ₩2 billion. Since the fourth quarter of last year, sales have risen significantly on the basis of COVID-19 prevention issues. Its sales in fourth quarter of last year are ₩3.5 billion and its sales in first quarter of this year are ₩4 billion. In the case of Gaviscon, the company generated ₩2.3 billion in sales in the first quarter of 2016, just before the boycott began, but has since maintained sales of around ₩1 billion. Its sales in first quarter of this year are ₩1.2 billion. In five years, it has fallen by 46%. Gaviscon's rival, Yuhan's Almagel, has seen a modest rise in sales since the boycott. Its first quarter sales were ₩3.2 billion and it was the highest ever. Another competitor, Boryung's Gelfos, had sales similar overall to those before the start of the Gaviscon boycott. Its first quarter of this year's sales were about ₩2.4 billion. Analysts say that the sluggish sales of Gaviscon & Strepsils are due to the company's passive advertising and marketing activities. In fact, Reckitt Benckiser had been actively advertising and marketing both products before the boycott began. According to the KFAA's Advertising Information Center statistics, Reckitt Benckiser was included in the top 100 advertisers, spending ₩2.2 billion as of January 2016, but has disappeared since 2017.
- Company
- Keytruda, passed the committee except for lung cancer
- by Eo, Yun-Ho May 31, 2021 06:01am
- According to the industry, yesterday (26th) the HIRA's Cancer Drugs Benefit Appraisal Committee recognized the appropriateness of immuno-cancer drug Keytruda (Pembrolizumab)'s ▲ bladder cancer 2nd or higher ▲ typical Hodgkin lymphoma solo therapy that recurred after 3rd treatment. In fact, NSCLC, Non-small Cell Lung Cancer's indication of primary solo and combined therapy failed to pass the Cancer Drugs Benefit Appraisal Committee on the eighth challenge. This is likely to make it virtually difficult to expand the benefit of Keytruda's indications of lung cancer. It has been discussing the benefit expansion since September 2017. It's been almost four years now. The biggest challenge at the time was the "burden of pharmaceutical companies for the initial third cycle of medication," which the government presented as a condition for expanding the benefit to pharmaceutical companies with immuno-cancer drugs. Roche, a company with "Tecentriq(Atezolizumab)" which was generic at the time, accepted the proposal, and failed to accept two types of PD-1 inhibitors, including Keytruda and "Opdivo(Nivolumab)." The MSD then repeatedly proposed and revised compromises. The final discussion was in August last year. At that time, the Cancer Drugs Benefit Application Committee held off because it believed there was a lack of compromise. The HIRA then resubmitted the financial contributions discussed at the Cancer Drugs Benefit Appraisal Committee to MSD in September of the same year, demanding a revision. MSD submitted the revised bill a month later and handed it over to the Cancer Drugs Benefit Appraisal Committee for discussion. Eventually, the introduction of the Cancer Drugs Benefit Appraisal Committee was delayed, and the MSD persuaded the government directly by the new CEO Kevin Peters, but the answer was NO. There may be a reason, but even the failure of third-generation EGFR TKI 'Tagrisso' (Osimertinib) and Keytruda in April, the expansion of the benefits of the first treatment for lung cancer is facing difficulties.
