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- 2026-03-17 23:19:10
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- Leclaza can be prescribed at general hospitals
- by An, Kyung-Jin Sep 09, 2021 05:54am
- Leclaza Leclaza(Lazertinib Mesylate Monohydrate), a new domestic drug, is targeting the domestic lung cancer treatment market. As more than 30 major medical institutions nationwide were able to prescribe in about eight months of domestic permission, it has entered the domestic market competition, which forms 150 billion won a year. According to the industry on the 6th, Yuhan's Leclaza passed the drug committee of more than 30 medical institutions within two months of the launch of the benefit. It can be prescribed at Seoul National University Hospital, Sinchon Severance Hospital, Samsung Medical Center, and Asan Medical Center, as well as upper-level general hospitals called "Big 4," National Cancer Center, Bundang Seoul National University Hospital, Seoul St. Mary's Hospital, Hwasun Chonnam National University Hospital, Chilgok Kyungpook National University Hospital, and Pusan National University Hospital. Leclaza became the 31st new drug to be developed in Korea with conditional approval from the MFDS on January 18 this year. Patients with T790M-resistant local progressive or metastatic non-small cell lung cancer such as Iressa (Gefitinib), Tarceva(Erlotinib HCl), and Giotrif (Afatinib Dimaleate) are subject to administration. It is a mechanism that inhibits the proliferation and growth of lung cancer cells by interfering with signaling involved in lung cancer cell growth. Yuhan released it on July 1. and applied for insurance registration on December 30 last year before the item license using the "Drug Approval-Patent Linkage System," and achieved high-speed registration 165 days after the license. Despite its therapeutic effectiveness and safety comparable to AstraZeneca's Tagrisso (Osimertinib Mesylate), which acts as the same mechanism, it was recognized for its adequacy by offering low drug prices. Academic organizations consisting of clinical specialists such as the Korean Cancer Study Group, The Korean Cancer Association, Korean Society of Medical Oncology, and Korean Association for Long Cancer also showed similar efficacy and safety to Tagrisso and had a low risk of heart toxicity. It will be a new treatment alternative for patients with local progressive and metastatic non-small cell lung cancer with EGFR T790M mutations." EGFR mutation is a very common type of mutation observed in 30-40% of non-small cell lung cancers that account for 80-85% of lung cancer, occurring between exon No. 18 and 21. It is known to be more prevalent in Asians. EGFR-TKI, which can be prescribed in Korea until the release of Leclaza, is the first-generation drugs Iressa and Tarceva, Giotrif, Vizimpro, and Tagriso. According to IQVIA, a pharmaceutical research institute, five EGFR-TKI types formed a market worth 74.3 billion won in the first half of this year. Tagrisso, classified as a third-generation drug like Leclaza, accounts for 70% of the total market with 52 billion won in sales. Based on the recommended daily dose, Leclaza's insurance upper limit is about 206,900 won. It is about 10,000 won cheaper than Tagrisso (217,782 won). An official from Yuhan said, "We are happy for Leclaza to pass the DC of major university hospitals and general hospitals nationwide at the same time as insurance benefits.With the start of Leclaza prescription in July, positive treatment effects are being derived from the treatment site." He said, "If more medical institutions can prescribe within this year, we will contribute to improving the unmet medical needs of cancer patients in Korea."
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- Alunbrig proves the effectiveness of epilepsy patients
- by Sep 09, 2021 05:54am
- Competition is fierce for the first standard treatment as the second and third generation drugs, which are next-generation drugs, appear one after another in the ALK-positive non-small cell lung cancer treatment market. Target anticancer drugs targeting ALK mutations include the first generation Xalkori (Crizotinib), the second generation Zykadia (Ceritinib), "Alecensa (Alectinib HCl), and the third generation Lorviqua (Lorlatinib). A generational shift is taking place in Xalkori, which has long been the first standard treatment. Except for Lorviqua, which still has only secondary treatment indications, Roche's Alecensa and Takeda's Alunbrig are the most fiercely competitive drugs in Korea. Both are second-generation drugs and are similar, showing excellent effects on patients with brain metastasis. Alunbrig, which was released relatively late, has different convenience and tolerability from Alecensa. Dr. Ross Camidge ( University of Colorado Cancer Center), who participated in the Alunbrig online media session held by Takeda Pharmaceutical Korea on the 3rd, showed similar results that he was superior to Xalkori through phase 3 clinical trials of Alunbrig and Alecensa. This is also the case in patients with epilepsy, he said. The secondary factors Dr. Ross Camidge refers to convenience, safety, tolerability, and cost. In this respect, he said Alunbrig is a good drug to choose from as the primary treatment. Looking at the convenience, Alcensa needs to be taken 8 capsules a day and Alunbrig needs to be taken only once a day (two tablets a day in some countries). In terms of quality of life, Alunbrig maintains a high quality of life for a long time. Dr. Ross Camidge explained, "In Alunbrig clinical trials, the time point at which the Crizotinib group recorded a lower quality of life than Alunbrig was faster than expected." Early-Onset Pulmonary Events (EOPE) were also concluded to improve when the drug was stopped for a while and then taken again. Referring to this, Dr. Ross Camidge added, "If you are worried about lung abnormalities, you will not take 90mg for seven days from the beginning, but 30, 60, and 90mg for three days each, and the method of slowly increasing will be effective." Lorviqua, a third-generation drug, was diagnosed with great side effects. He said, "The PFS risk ratio of Lorviqua's phase 3 CROWN study shows the best number among existing treatments," but added, "However, there are significant side effects, with about 80% of patients taking additional drugs with cholesterol levels, and half suffer from central nervous system functional problems. Even when looking at the quality of life data, the quality of life deterioration patterns of Lorlatinib and the control group (Crizotinib) overlap considerably, he said. For this reason, controversy still persists over whether Lorviqua should be viewed as a primary treatment option. Dr. Ross Camidge said, "Personally, Lorviqua is better to be used in secondary or higher treatment situations," adding, "In particular, ALK-positive lung cancer means that there is no need to use highly toxic drugs from the beginning of treatment." He said, "If we have to use Lorlatinib as a secondary drug like Korea, we will choose Alunbrig, which has better convenience and resistance, rather than Alecensa, as the primary treatment."
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- It would have been a big trouble if no improvement
- by Chon, Seung-Hyun Sep 08, 2021 06:07am
- Pharmaceutical companies are actively working on transferring drug copyrights. As drug prices of transfer and transfer drugs are allowed, the transfer of permission rights due to mergers and acquisitions or corporate separation is speeding up. It is trying to enter the new generic market by receiving expensive products from other companies. According to the MOHW on the 7th, Celltrion's Actos 15mg will be newly listed on the health insurance benefit list at 626 won starting this month. The copyright of Actos 15mg will be changed to Celltrionl. Takeda Korea's Actos 15mg was removed from the list. It is a follow-up measure to Celltrion's acquisition of Takeda's drugs. Celltrion acquired Takeda's primary care division in the Asia-Pacific region for $278 million in June last year. Takeda has all rights to patents, trademarks, and sales of 18 pharmaceutical products sold in Korea, Thailand, Taiwan, Hong Kong, Macau, the Philippines, Singapore, Malaysia, and Australia. In Korea, Celltrion will take over the rights of Takeda products acquired by Celltrion. Celltrion is in the stage of completing the transfer of rights in Korea through the procedure of changing permission rights and registering drugs. The price of Actos 15mg remains the same as the previous drug price of 626 won. The previous upper limit of 626 won was maintained as the drug price succession rule was newly established in January. If the right to Actos 15mg was changed last year, drug prices are likely to have fallen significantly. Due to the reorganization of the drug price system in July last year, the drug price system was implemented, where the drug price fell as the registration time was delayed. If there are more than 20 identical registered products, generic will have a 15% lower drug price. At this time, the transfer drug was listed at the lowest price among the same products due to the application of the step-type drug price system. If the drug license is changed, it goes through a procedure of deleting and re-registration. Even if it was a previously registered product, it was inevitable to apply a step-type drug price system. When the pharmaceutical industry pointed out that it was unfair to register transferred drugs in the same way as newly registered products, the MOHW accepted the improvement of the system improvement. With the revision of the regulations, Actos was able to maintain the previous drug price of 626 won. Singulair Chewable 4mg of Organon Korea has been listed at 693 won since this month. As the license was changed to Organon, a new corporation spun off from MSD Korea, it was newly listed on the health insurance benefit list. The 4mg Singular Chewable has 59 identical products listed. If 4mg of Singular Chewable is recognized as a newly registered product, it cannot exceed 322 won. As drug prices were allowed to succeed, drug prices avoided falling below half. Organon's Vytorin 10/10 and Vytorin 10/20 were listed at 782 won and 1,093 won, respectively. Vytorin 10/10 and Vytorin 10/20 each have 48 generics listed, so new licensed products are subject to the step-type drug price system. If Vytorin 10/10 is applied as a newly registered product, it cannot exceed 481 won. However, due to the improvement of the system, the previous drug price was applied as it was.
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- Tagrisso has established itself as an EGFR treatment
- by Sep 07, 2021 05:53am
- Lung cancer is the No. 1 cancer death rate among Koreans, but treatment is greatly evolving, with the 5-year survival rate more than tripling over 20 years. What had a significant impact on this was the EGFR target treatment. Targeted treatments targeting EGFR mutations have dramatically improved the overall survival period of patients. Among them, the third generation 'Tagrisso (Osimertinib)' has clearly established itself as a standard treatment for non-small cell lung cancer with current EGFR mutations. Tagrisso is a third-generation EGFR-TKI that inhibits both EGFR variations and T790M variations represented by L858R and exon 19 deficiencies. It is the only third-generation EGFR-TKI that has shown a full survival period of more than three years, which is excellent for patients with brain metastasis. AstraZeneca succeeded in the first generation of Iressa and the third generation of Tagrisso. Tagrisso's global sales reached $4.33 billion as of last year, becoming the first blockbuster drug in five years. Ironically, Tagrisso is going through all sorts of ups and downs in Korea. It's been a problem since the first registration. Since its first rapid approval in the United States in November 2015, Tagrisso has been the fifth in the world to obtain an item permit in Korea. At that time, Olita, the same third generation, was released in Korea. Tagrisso was the only third-generation drug in the world, but competed with Olita in Korea. Tagrisso was "too expensive" for the government, compared to Olita, which offered relatively low prices. In November 2016, the HIRA declared Tagrisso as a non-reimbursement drug, equivalent to the economic evaluation exception scheme. It passed the committee after three challenges, but negotiations with the NHIS were not easy. It was first listed as a secondary treatment in December 2017. Olita's development was suspended due to safety issues, and Tagrisso's quarterly sales jumped from ₩3 billion to ₩10 billion based on IQVIA. However, the Asian subanalysis data of the 2019 FLAURA 3-phase study became a problem. FLAURA is a global clinical trial that identifies Tagrisso's efficacy and safety as a primary treatment. Overall clinical results demonstrated improvement over first-generation drugs with a total survival period of 38.6 months. The problem was the result of a sub-analysis that only Asians did separately. The risk ratio (HR) of the Asian subgroup is 0.995, which is virtually no difference from the control group based on 1. AstraZeneca also submitted FLAURA China data for Chinese to reaffirm its effectiveness in Asians, but failed to pass the Cancer Drugs Benefit Appraisal Committee. Two years have passed since the first treatment indication was added, but conditions have no longer evolved since December 2017. Tagrisso's sales are steadily increasing. According to IQVIA, Tagrisso's annual sales reached ₩59.4 billion in 2018 and ₩79.2 billion in 2019. Last year, its annual sales surpassed ₩100 billion for the first time with ₩106.5 billion. It has become a global primary standard treatment. This year, Tagrisso's situation is not so good. First of all, after Olita, Yuhan's Leclaza is the second competitive drug. The UK, which was passive in primary care benefits due to its high cost, also recognized Tagrisso as primary standard treatment last year and applied the benefits. Currently, 44 countries around the world, including the United States, Britain, Germany, France, Italy and Japan, recognize Tagrisso as a primary treatment. Despite the controversy over the Asian OS, major Asian countries recognize Tagrisso as a primary treatment. Tagrisso is also applied as the first benefit in major Asian countries such as Japan, China, Taiwan and Singapore. After all, Tagrisso's benefit is an irresistible global trend. However, as two years have passed, complaints from patients are growing. It is noteworthy whether Tagrisso will be able to cross the high barrier of salary expansion amid changes in global treatment flow and demands from patients.
- Company
- Downfall of Cialis·Viagra…market taken over by generics
- by Chon, Seung-Hyun Sep 06, 2021 05:59am
- ‘Viagra,’ which had once held a commanding lead over the erectile dysfunction treatment market, is having trouble making a comeback. After being taken over by domestic generics Palpal,’ and ‘Sendom,’ it had also been outrun by another local generic, ‘Gugu.’ Lilly’s Cialis is also having trouble making a comeback due to generic competition. According to the pharmaceutical research institution IQVIA, the oral erectile dysfunction treatment market in Q2 marked ₩29.5 billion, showing a 48% YOY increase. Also, this was a 3.1% increase from the previous quarter. The erectile dysfunction treatment market had seen a reduction in sales in Q1 and Q2 of last year and had only started making a recovery since the second half of last year. In 1H last year, the reduced number of patients’ hospital visits as well as restrictions in sales and marketing due to the spread of COVID-19 had slowed down sales, but the market recovered to the previous year's level from the second half of the year. Generics from domestic companies are showing increasing influence over the market. Hanmi Pharm’s Viagra generic Palpal sold ₩5 billion in Q2, solidifying its lead in the market. Palpal’s sales had fallen 4.4% YOY, but still had a far lead over the runner-up by that makes around ₩2 billion in quarterly sales. Palpal, which was released immediately after Viagra’s patent expiry in 2012, had surpassed Viagra’s sales in Q2 2013 and Cialis’s sales in Q4 2015, then has been holding the lead in the erectile dysfunction treatment market for 6 years. Chong Kun Dang’s Cialis generic Cendom kept its 2nd place by selling ₩2.7 billion in Q2, a 5.6% YOY increase. Cendom, which was released after Cialis’s patent expired in September 2015, gradually increased its share in the market to surpass its original Cialis in Q4 2017 and Viagra in Q4 2018 and reach second place in the overall erectile dysfunction treatment market. Hanmi Pharm’s Cialis generic Gugu also marked 3rd place for the first time since its release. Gugu sold ₩2.2 billion in Q2, making a 9.5% YOY increase. Gugu’s sales had surpassed Cialis in Q2 2019 and Viagra for the first time in this term. On the other hand, originals from multinational pharmaceutical companies had not shared such positive performance in sales. Viatris Korea’s Viagra sold ₩2.1 billion in Q2 and increased 1.0% YOY, but still gave way to Gugu and lost its 3rd place in the market. This was the first time Viagra had ranked 4th in the erectile dysfunction treatment market. Viagra lost its lead in 2013 to Palpal, then became 3rd place in 2018 being outrun by Cendom. Since then, the product had stayed in its place for 2 years but then was surpassed by Gugu this year. Viagra, which had once represented the erectile dysfunction treatment market, is now selling less than half of what Palpal sells. Sales of Lilly’s Cialis also fell 6.5% YOY to mark ₩1.5 billion in Q2. The drug had held a strong lead in the market for 3 years, from Q3 2012 to Q3 2015, but had to hand over the lead in the domestic erectile dysfunction treatment market to Hanmi’s Palpal upon patent expiry. Since then, Pfizer's Viagra and Chong Kun Dang’s Cendom had sequentially exceeded Cialis’s sales. In 2018, Lilly had signed an agreement with its former sales partner, Handok, for the domestic distribution, marketing, and sales of Cialis, but saw no recovery in sales.
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- Forxiga will become a basic treatment for chronic kidney dz
- by Sep 06, 2021 05:58am
- "SGLT-2 inhibitors are no longer diabetes drugs. It will be recognized by doctors of kidney medicine as a basic medicine that protects kidney function and is good for use with other medicines." Physicians expect SGLT-2 inhibitors, which have expanded their scope to kidney treatments. Choi Bum-soon, a professor of kidney medicine at the University of Catholic Medicine at Eunpyeong St. Mother's Hospital, commented on the new treatment option "Forxiga (Dapagliflozin)" that appeared in more than 20 years at an online press conference. From the left, Professor Ko Kang-ji of Korea University Guro Hospital, Professor Yang Chul-woo of Seoul St. Mary AstraZeneca's Forxiga was the first SGLT-2 inhibitor to obtain kidney medication. Forxiga, which began with diabetes drugs, was foreseen through several studies. Forxiga showed decreased cardiovascular events, kidney protection benefits, and decreased albuminuria in the DECLARE-TIMI 58 study of diabetics. The subsequent DAPA-CKD study demonstrated excellent kidney protection in patients with chronic kidney disease with a tetrahedron filtration rate of 25 to 75μg/min/1.73㎡, regardless of type 2 diabetes. "There have been few drugs to help patients not to deteriorate their kidney function," said Koh Kang-ji, a professor of kidney medicine at Korea University's Guro Medical School, at a meeting on the 30th to commemorate the addition of Forxiga chronic kidney disease. "The RAAS blocker worked, but it was 20 years ago that Forxiga was very welcome, and because it effectively reduces the pressure in the glomerulus as a different mechanism than the RAAS blocker, it can be used complementively." Professor Ko emphasized Forxiga's role in early patient treatment. "If we use Forxiga in early patients, we can effectively reduce chronic progression by increasing eGFR and we can use it effectively and safely," he said. "We need to make various efforts to increase the diagnosis rate of mild patients and quickly apply Forxiga." Choi gave advice on the proper use of drugs through Forxiga. The DAPA-CKD study found that the Forxiga administration group had a lower eGFR than the control group at the beginning. Professor Choi said, "Because the graph crossover over time, it is important for the medical team to confidently talk about patients' anxiety." "A 10% decrease compared to the baseline is a temporary phenomenon, and if more than 30% changes, we choose to temporarily stop and rewrite medicine." He added, "Since using Forxiga may cause dehydration, it is recommended to be careful of use in elderly people and patients scheduled for endoscopy and surgery the next day, and urinary tract infections are not worth worrying about." In its revised guidelines for treating heart failure announced this month, the ESC recommended SGLT-2 inhibitors such as Forxiga and Jardiance as primary treatments for patients with HFrEF. As Jardiance demonstrated its effectiveness in cardiac output coefficient-preserving heart failure (HFpEF) patients, the scalability of SGLT-2 inhibitors was further broadened. The medical team predicted that SGLT-2 inhibitors will become a major treatment option even in kidney disease. Yang Chul-woo, professor of kidney medicine at Catholic University's Seoul St. Mary's Hospital, said, "In order to live a long life as a joke, anti-hypertensive drugs such as Aspirin, Statins, and RAAS are essential, and the fourth drug is Forxiga (SGLT-2 inhibitor)." "We believe that SGLT-2 inhibitors will become a basic drug, and Forxiga is playing an important role as a leader," he said.
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- Boryung released Avastin Biosimilar for the first time
- by An, Kyung-Jin Sep 05, 2021 08:24pm
- View of Boryung headquarters buildingBoryung announced that it will sell its anti-cancer biosimilar "Onbevezy" introduced by Samsung Bioepis in the domestic market from the 1st. Onbevezy is a biosimilar product of the blockbuster anti-cancer drug Avastin (Bevacizumab) developed by Roche. Samsung Bioepis proved the equivalent effect and safety of its original product Avastin through Phase 1 and Phase 3, and received approval for domestic items as the first biosimilar of Bevacizumab in March. It has indications such as metastatic direct colon cancer, metastatic breast cancer, non-small cell lung cancer, progressive or metastatic neoplasm, glioblastoma, epithelial ovarian cancer, ovarian cancer, primary peritoneal cancer, and cervical cancer. In May, Boryung signed an exclusive contract with Samsung Bioepis for Onbevezy 100mg and 400mg. It plans to expand its influence in the anti-cancer drug market by releasing products simultaneously with the listing of drug benefits on September 1. By adding biosimilar anti-cancer drugs to its portfolio, it is also expected to increase its competitiveness in the anti-cancer drug sector. As of 2019, Avastin recorded about ₩8.8 trillion in sales in the global market. In South Korea, it formed a market worth ₩118 billion (IQVIA) based on accumulated sales last year. Onbevezy is 37 % cheaper than the original Avastin. It has a longer expiration date from 24 months to 36 months. "Onbevezy is cheaper than Avastin," said Kim Young-seok, head of the Boryung anti-cancer drug division. It will be an alternative to ease the financial burden of patients and increase the performance of treatment. "We will actively try to settle in the market quickly through synergy between Samsung Bioepis' product power and Boryung's sales competitiveness."
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- Academia supports 1st-line reimbursement of Tagrisso
- by Eo, Yun-Ho Sep 03, 2021 06:03am
- The lung cancer societies are supporting the need to extend insurance benefits for ‘Tagrisso’ to 1st line treatment in lung cancer. In July, AstraZeneca Korea had reduced the standards and reapplied to extend reimbursement to the reduced scope for its 3rd generation EGFR TKI Tagrisso (osimertinib). However, the Health Insurance Review and Assessment Service had decided not to deliberate Tagrisso’s reimbursement as an agenda at the Cancer Disease Deliberation Committee meeting in September. However, still, HIRA had sought opinions from relevant societies, including the Korean Association for Lung Cancer, the Korean Society of Medical Oncology, and the Korean Cancer Study Group. All the societies have expressed support for Tagrisso’s 1st-line indication and submitted opinion statements that a reimbursement extension is necessary, even for the reduced standard. The key strategy for approval of the insurance benefit this time is in the reduced benefit standards. In its application, AstraZeneca reduced the scope of its reimbursement to ‘1st-line treatment of patients with EGFR exon 19 deletion or those with brain metastasis’ rather than in line with its indication of ‘NSCLC patients whose tumors have EGFR mutations, with exon 19 deletions or exon 21 (L858R) mutations.’ In other words, the company adopted the strategy to increases the justification of Tagrisso’s efficacy and treatment benefits. Narrowing the scope of reimbursement would naturally allow for a broader discussion on its fiscal impact. So HIRA decided to collect the society’s opinion on the proposal for the reduced scope of reimbursement. On this, the lung cancer societies have submitted an opinion statement that states “Tagrisso needs to be reimbursed for 1st line NSCLC according to its indication. Therefore, the society sees no problem reimbursing the drug for the reduced scope of standards, and support its coverage extension.” An official from one lung cancer society said, “The drug has already demonstrated statistically significant benefit through a Phase III study and should be reimbursed according to this indication. However, as the agenda continues to be unable to pass the CDDC review stage, we submitted an opinion statement that reimbursement should be first approved for patients in urgent need of such prescriptions.” Tagrisso had added the indication for 1st-line treatment of lung cancer in Korea in December 2018 and aimed to expand its reimbursement to the indication in 2019. However, at the Cancer Disease Review Committee meeting in October, the committee decided to defer the decision until the full data from the Phase 3 FLAURA trial that studied the overall survival (OS) of NSCLC patients in 1st line is disclosed. Although AstraZeneca had submitted the full FLAURA data and expressed their will to accept most of the cost-sharing plan proposed by the government, the reimbursement fell through due to opposition from committee members (specialists) due to issues on the drug’s clinical efficacy. AstraZeneca had attempted to reverse the decision by submitting the OS evidence confirming Tagrisso’s OS benefit in Asian patients from the FLAURA China study, but the committee’s response was, once again, a ‘No.’ After Tagrisso failed to receive reimbursement in April, 1,713 lung cancer patients and their families sent an appeal to the government, the Korean Association for Lung Cancer, and AstraZeneca, “imploring approval for the 1st-line reimbursement of Tagrisso.”.
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- Kymriah was virtually pending at the Committee
- by Eo, Yun-Ho Sep 02, 2021 05:59am
- It wasn't easy: the listing of the super expensive one-shot treatment 'Kymriah's insurance benefits was discussed but put on hold. According to related industries, Novartis Korea's world's first CAR-T treatment, Kymriah(Tisagenlecleucel), was virtually pending at the HIRA Cancer Drugs Benefit Appraisal Committee on the 1st. However, based on the amendments mentioned in the commission, it is said that the discussion will proceed quickly. Kymriah's indications are Diffuse Large B-Cell Lymphoma (DLBCL) and B-cell Acute Lymphocytic Leukaemia (ALL) in children and young adults. Both are subject to terminal patients who are not effective in treating more than one or who have recurred after re-occurrence or transplantation. The Cancer Drugs Benefit Appraisal Committee reportedly responded positively to ALL, especially to children with high life expectancy, and skeptical responses to lymphoma. Kymriah, which was licensed in March, quickly submitted the benefit using the "Medicine Approval-Patent Linkage System." However, the Korea Leukemia patients organization criticized the government and Novartis after the Cancer Drugs Benefit Appraisal Committee failed to be presented in July. However, it is hard to predict whether ALL indications will be registered. The drug costs about ₩500 million per dose, and variables such as the NHIS negotiation can occur. Yoo Chul-joo, a professor of pediatric blood oncology at Severance Hospital, said, "Although recurrence and non-responsiveness ALL patients in Korea are extremely rare, we expect similar cases in Korea as the government, pharmaceutical companies, and medical community work together to treat them quickly with Kymriah." If Kymriah is listed, it is likely to be linked quickly to actual prescriptions. Currently, Big 5 general hospitals such as Seoul National University Hospital, Asan Medical Center, Seoul St. Mary's Hospital and Sinchon Severance Hospital are undergoing management procedures, including human cells, and Samsung Medical Center has already completed approval. In the case of Seoul National University Hospital, Kymriah passed the DC in April, and passed at SMC in May .
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- First IV acetaminophen+ibuprofen combo lands in Korea
- by An, Kyung-Jin Sep 02, 2021 05:59am
- Product picture of Maxigesic IV being sold abroadAn acetaminophen+ibuprofen solution for infusion will soon be released in the Korean pharmaceutical market. Whether the introduction of a new combination therapy option in the single drug-oriented nonopioid analgesic infusion space is gaining attention. According to industry sources on the 1st, Kyongbo Pharmaceutical had received marketing authorization for ‘Maxigesic IV’ from the Ministry of Food and Drug Safety on the 30th of last month. ‘Maxigesic IV’ solution’ is a unique solution combining two nonopioid analgesics- 1000mg acetaminophen with 300mg ibuprofen - for intravenous infusion. Recently, a different pharmaceutical company had applied for an oral drug that contains the same ingredients as an OTD drug but failed. Maxigesic IV was first developed in a tablet form by AFT, a New Zealand pharmaceutical company, to be sold as an OTC, but had switched formulations to be used to manage moderate-to-severe post-operative pain. In November 2018, Kyongbo Pharmaceutical had signed an exclusive development and sales agreement for ‘Maxigesic’ with AFT. The company will be importing the finished product from AFT to sell domestically. The agreement is valid for 15 years from the date of the product release. The two ingredients contained in ‘Maxigesic' -acetaminophen and ibuprofen- are the most widely used antipyretic analgesics. A Phase III clinical trial conducted by AFP on 276 adult patients with at least moderate pain following bunion surgery demonstrated that Maxigesic IV significantly relieved pain within 10 minutes after IV infusion. As a combination solution for infusion, the drug offers higher pain relief than acetaminophen or ibuprofen alone and develops fewer cardiovascular or gastrointestinal side effects. The drug has been received as a potential option that may reduce the use of opioid analgesics that even may replace the market for such drugs. With those strengths, AFP has finished submitting applications for drug approval in 21 countries worldwide, including in major European countries and Australia. The Belgian pharmaceutical company Hyloris Pharmaceuticals, which signed a licensing agreement with AFP for ‘Maxigesic,’ has also been taking steps to receive approval for the drug by the U.S. FDA. Analgesic effect of Maxigesic IV solution(Source: AFP, Hyloris Pharmaceuticals) With the domestic approval, Kyongbo Pharmaceutical is planning to hasten the release of the first IV solution that combines acetaminophen and ibuprofen. An official from Kyongbo Pharmaceutical said, “With a high unmet need remaining in the nonopioid analgesic market, an IV solution that combines two of the most commonly used analgesic ingredients may have the potential to exert and expand its influence in the field of analgesics.
