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- 2026-03-17 23:19:10
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- Sputnik V's lot release is imminent
- by Kim, Jin-Gu Sep 02, 2021 05:59am
- The Russian COVID vaccine Sputnik V is about to be released, Korus Pharm said on Tuesday. According to Korus Pharm, local administrative procedures for Sputnik V's lot release are being finalized. The production of finished products with a capacity of 1000L has already been completed, and it is expected that the product will be released in earnest once the quality check is completed at the Gamaleya Institute in Russia. In late July, Korus Pharm completed quality verification of Sputnik V's validation badge from the Gamaleya Institute in Russia. Production of 1000L DS was completed in mid-August. Korus Pharm has maintained production of 4 million doz per share, and is expected to increase production to 6 million doz per share starting this month. If bio-reactor is added, it will have a production capacity of more than 10 million doz per week. In addition, Korus Pharm explained that Kirill Alexandrovich Dmitriev, CEO of Russia's RDEF, will visit Korea to commemorate the full-fledged lot release, and is currently discussing his visit to Korea. Kirill Alexandrovich Dmitriev will visit to discuss contracts for additional supplies under the lot release of commercial supplies. "As soon as Russia's local administrative procedures are completed, we will start mass production and establish a shipping process," "As soon as the Russian administrative process is completed, we will mass-produce and establish a shipping process," a Korus Pharm company official said. "We hope that more vaccines will be supplied around the world to help with collective immunity of COVID-19."
- Company
- SK Bioscience has started clinical trial of GBP510
- by Chon, Seung-Hyun Sep 02, 2021 05:59am
- Phase 3 of COVID vaccine developed in Korea have begun in earnest. SK Bioscience announced on the 30th that it has started administering the first subjects of phase 3 clinical trials of GBP510, jointly developed by the Institute for Protein Design (IPD) at the University of Washington. This is the first phase 3 clinical trial of a candidate substance for COVID vaccine developed in Korea. Previously, SK Bioscience received approval from the MFDS on the 10th for clinical trial of GBP510. Phase 3 of GBP510 will be held in 14 domestic institutions, including Korea University and Guro Hospital, and 4,000 domestic and foreign adults over the age of 18 in Europe and Southeast Asia. GBP510 is mixed with GSK's Pandemic Immunostimulator (Adjuvant) and is injected twice every 28 days. SK Bioscience, along with the International Vaccine Institute (IVI), a non-profit international organization in East Europe and Southeast Asia, is applying for approval of each country's Phase 3 clinical trial plan. It is planning to start clinical trials overseas as early as next month. SK Bioscience plans to secure interim data in the first half of next year by evaluating the immunogenicity and safety of GBP510 through Phase 3 clinical trial conducted at home and abroad. With prompt permission from Korean health authorities, it will also begin preparation for the WHO certification and acquisition of Emergency Use Authorization by each country. SK Bioscience confirmed that as a result of Phase 1/2, Phase 1 clinical trial conducted on 80 healthy adults, 100% of neutral antibodies that neutralize COVID were formed in the dosing group that administered both GBP510 and immune enhancer. This is measured through international standard substances and evaluation methods established by the WHO and the NIBSC. In terms of safety, no significant adverse event has occurred that is related to the administration of GBP510. SK Bioscience is also monitoring safety of 247 participants in the second stage, which includes senior citizens. No particular safety issues have occurred so far. The company predicted, "When the development of the GBP510 is completed, the difficulty of supply and demand of COVID vaccine in Korea, which relies on imports, will be resolved." If GBP510 successfully enters the commercialization stage, it can establish and supply its own production and supply plan as it is a vaccine for domestic development. In the long term, it is expected that it will contribute to securing vaccines as it can quickly cope with mutant viruses based on platform technology. The synthetic antigen vaccine platform applied to GBP510 can be stored under refrigeration conditions of 2 to 8°C, so it can be distributed using the existing vaccine logistics network and can be stored for a long time, so it can easily secure accessibility globally. GBP510 was selected as the first target of the Wave 2 project, which CEPI operated last year to support differentiated COVID vaccine candidates, and hundreds of millions of vaccinations will be supplied to the world including South Korea through the COVAX facility once the development is completed. SK Bioscience' vaccine factory in Andong has the capacity to produce hundreds of millions of commercial products a year immediately after developing the vaccine and manufacturing various types of vaccines simultaneously through independent spaces in nine areas of the plant. "With the rapid and systematic cooperation of health authorities and clinical institutions, we have successfully started to administer subjects. We will thoroughly verify safety and effectiveness through clinical trials."
- Company
- It is necessary to provide Kymriah treatment accessibility
- by Sep 02, 2021 05:59am
- Novartis Korea (CEO Kim Skafte Mortensen) announced on the 30th that the ICBMT released the results of a study that analyzed the treatment of DLBCL patients in Korea from August 26 at ICBMT. DLBCL is an aggressive lymphoma that accounts for about 40% of non-Hodgkin lymphoma. Although most standard treatments show abnormalities in part, it is known that 10 to 15% of patients do not respond to primary treatments and 20 to 35% experience recurrence. The study was conducted to identify the demographic characteristics and treatment patterns and prognosis of DLBCL patients in Korea. Led by Professor Park Mi-hye, College of Pharmacy, Sungkyunkwan University, a total of 4931 claims of the HIRA were analyzed from January 1, 2013 to July 31, 2019. The analysis found that the median of the overall survival of DLBCL patients who failed secondary treatment was 4.73 months. In addition, about 70% of patients who failed the second treatment were repeatedly undergoing salvage chemotherapy, and the duration of the second treatment to the third treatment was gradually shortened to 2.86 months (median) and 1.81 months (median) to the fourth treatment. "This study confirmed the poor treatment prognosis and limitations of current treatment of recurrence and non-responsiveness DLBCL patients in Korea," said Park Mi-hye, a professor at Sungkyunkwan University, who led the study. "There are no alternative treatments and poor prognosis. "This is the first study that has been analyzed for all patients in Korea using all data on claim data." She added, "In the end, the patients were repeating salvage chemotherapy, which is difficult to expect a life extension due to the absence of treatment options, and as the number of treatment increases, the length of failure will be shorter, so patients who are unable to expect further reactions need available treatment options." Poor prognosis and the need for effective treatment options in patients with recurrent and non-responsive DLBCL have already been confirmed through global research. According to the SCHOLAR-1 study, the first patient-level analysis result for non-responsive DLBCL patients, the complete response rate for non-responsive DLBCL patients was 7% and the median duration was only 6.3 months. Further analysis of the CORAL study, a multi-organ, randomized clinical trial, also showed that the expected survival rate for one or two years among patients with recurrent and non-responsive DLBCL, especially those who failed secondary relief chemotherapy, was 23% and 15.7%, respectively. "This analysis is encouraging in that we can see the treatment patterns or prognosis of most patients in the actual benefit care environment," said Yoon Duk-hyun, a professor of oncology at Asan Medical Center in Seoul who participated in clinical consultation and research on DLBCL disease and domestic treatment status. Professor Yoon said, "Even though patients with recurrent and non-responsive DLBCL use repeated salvage chemotherapy, the period until the next treatment period was very short, with a median of two to three months, showing very poor prognosis because there are no effective alternative treatments." The new option CAR-T treatment, Kymriah, was the only one in Korea in March to prove a high response rate and persistence in a single treatment in a recurrent and non-responsive DLBCL patient. "Fortunately, new targeted treatments and cell treatments, which are completely different from conventional anticancer drugs, are under development or approval," Professor Yoon said. "However, most new treatments require improvement due to the high cost of patients."
- Company
- ‘Somavert’ is reimbursed and starts landing in GHs
- by Eo, Yun-Ho Sep 01, 2021 05:57am
- The new acromegaly drug ‘Somavert’ was listed for insurance benefit and has begun landing in general hospitals. According to industry sources, Pfizer Korea’s Somavert (pegvisomant) has submitted landing applications to drug committees at major medical institutions including the Seoul National University Hospital, Severance Hospital, and Seoul National University Bundang Hospital. As the Severance Hospital at Sinchon treats the most amount of acromegaly patients in Korea, Somavert is expected to be prescribed as soon as it passes the DC review. Somavert’s reimbursement has been approved and will be applied from the next month in September. Somavert was approved in Korea in September last year to treat patients with acromegaly who have had an inadequate response to surgery and/or radiation therapy and in whom an appropriate medical treatment with Somatostatin analogues did not normalize IGF-I concentrations or was not tolerated. The drug demonstrated its efficacy in the randomized, double-blind, pivotal study SEN-3614 that was conducted on 112 acromegaly patients for 12 weeks. The 112 patients were randomly assigned to administer 10mg, 15mg, 20mg of pegvisomant or placebo every day, and its primary efficacy endpoint was the percent change in serum IGF-I concentration from baseline to Week 12. Study results showed that in Week 12, the median serum IGF-I concentration reduction level was 16.8%, 26.7±27.9%, 50.1±26.7%, 62.5±21.3% for the placebo arm, and 10mg, 15mg, 20mg pegvisomant arm, respectively. Pegvisomant significantly reduced serum IGF-I concentrations in all three doses compared to placebo. The rate of patients whose serum IGF-I concentrations normalized compared to baseline were 10%, 54%, 81%, and 89% for the placebo arm and 10mg, 15mg, 20mg pegvisomant arm, respectively. Pegvisomant showed a significantly higher rate in all three doses compared to placebo. Also, pegvisomant significantly improved the overall sign and symptoms of acromegaly in all doses, and the incidence of adverse events was similar for all doses of the pegvisomant and placebo arm. Acromegaly is a rare condition characterized by the excessive secretion of growth hormones that causes abnormal, excessive secretion of IGF-I, and is most often caused by a benign tumor of the pituitary gland. Acromegaly is associated with clinical changes including reduced life expectancy, cardiovascular issues, enlargement of hands, feet and other organs, facial deformity, fatigue, joint pain, metabolic disorder, etc, and may be accompanied by and various secondary systemic complications including osteoarthritis, metabolic complications (insulin resistance, hyperglycemia, hyperlipidemia, etc), risk of neoplasms, hypopituitarism, vertebral fractures, and reduced quality of life. The annual incidence of acromegaly is estimated to be around 3.3 cases per 1 million population, and the worldwide prevalence is about 60 cases per 1 million. Retrospective analysis results that were announced in 2013 for Korea shows that around 1,350 acromegaly patients are registered in 74 secondary and tertiary medical institutions from January 2003 to December 2007, making the annual incidence rate in Korea to be 3.9 cases per 1 million, and prevalence to be 27.9 cases per 1 million in 2007.
- Company
- Sales of PARP inhibitor Zejula surpassed Lynparza in 2 years
- by Sep 01, 2021 05:56am
- PARP inhibitor Zejula (Niraparib tosylate monohydrate) outpaced its competitor Lynparza (Olaparib) in about 2 years. According to IQVIA, a pharmaceutical market research firm on the 31st, Zejula, Takeda's ovarian cancer treatment drug, recorded ￦3.5 billion in sales in the second quarter, surpassing Lynparza, which recorded ￦3.4 billion. Zejula, which started its first sales in the fourth quarter of 2019, started to grow rapidly in December 2020. Sales jumped from around ￦1 billion last year to ￦3.2 billion in the first quarter of this year. In the second quarter, it increased by 289% year-on-year to ￦3.5 billion. In the first quarter of last year, AstraZeneca's Lynparza, which previously dominated the market, showed ￦2.3 billion, ￦2.9 billion, ￦3.3 billion and ￦3.7 billion, respectively, but sales in the second quarter fell slightly to ￦3.4 billion. Zejula is also estimated to be ahead of Linpaza in the number of patients. As a result of converting the adjusted daily average number of pills into sales, Zejula was prescribed 34,900 days, Lynparza capsule and Lynparza tablet were prescribed 18,900 days and 7,700 days, respectively, in the second quarter. Lynparza and Zejula are both competing fiercely for ovarian cancer treatments before the PARP inhibition. Lynparza was approved in 2015. Zejula received a domestic permit in March 2019, much later than this, but it was applied to the secondary treatment in December 2020. Zejula outpaced Lynparza. This is because Lynparza and Zejula have concluded drug price negotiations with the NHIS over the expansion of primary maintenance benefits for ovarian cancer. The benefit range will be expanded together through the Health Insurance Policy Committee next month. Although the scope of ovarian cancer primary therapy indications for both products is expanded for Zejula, which can be used regardless of BRCA mutation, insurance benefits apply under the same conditions. This is because the HIRA Cancer Drugs Benefit Appraisal Committee recognized clinical usefulness only for BRCA training. Therefore, the two products are expected to compete from October when benefits are expanded.
- Company
- GS Cross’s Neulapeg sales jump fivefold in 3 years
- by An, Kyung-Jin Aug 31, 2021 06:14am
- The locally developed neutropenia treatment ‘Neulapeg’ is enjoying its belated prime. The drug, which was unable to make a presence earlier at the time of its release is continuing to break new records every quarter since signing a sales partnership with Boryung Pharmaceuticals. Neulapeg’s quarterly sales have risen over fivefold in the past 3 years, and are attempting to overtake the market leader position held by ‘Nelasta.’ According to the pharmaceutical market research institution IQVIA, sales of GC Cross’s ‘Neulapeg’ increased 64.8% YoY to reach ₩5.4 billion in Q2. Compared to Q2 2018, quarterly sales of the product increased over fivefold. ‘Neulapeg’ is a neutropenia treatment made with pegfilgrastim that was developed with GC Cross’s original technology. The drug is used on cancer patients during chemotherapy to prevent side effects of decreasing immunity that occur from a decrease in the neutrophil level. It received marketing authorization from the Ministry of Food and Drug Safety in August 2014 and began its sale in March of the next year. ‘Neulapeg’ applies the PEGylation technology that conjugates polyethyleneglycol to specific areas to improve the purity, stability, and half-life of the drug over existing therapies. Neulapeg is considered a 2nd generation drug as may be administered only once per chemotherapy cycle to see an effect compared to existing neutropenia treatments that are administered 4-6 times per cycle. Despite its strength of being nearly ₩300,000 cheaper than Kyowa Kirin’s ‘Neulasta(pegfilgrastim),’ Newlapeg wasn’t able to make much of a presence earlier at the time of its release. In its third year, 2017, Neulapeg had sold ₩3.2 billion, and then ₩4 billion in 2018. Quarterly sales of Neulapeg, which was less than ₩1 billion, started to soar after Boryung Pharmaceutical joined in as a sales and marketing partner with GC cross. In Q4 2018, its sales jumped from ₩1.1 billion to 1.3 billion in the following quarter, 1Q 2019, and then continued upwards ever since. GC Cross had signed a joint sales agreement for ‘Neulapeg’ with Boryung Pharmaceuticals in October 2018. GC Cross had attempted to work with Boryung and utilize the company’s sales capability in the field of anticancer to expand its share in the neutropenia treatment market. According to IQVIA, Neulapeg accumulated sales of ₩8.9 billion in 2019. This is a 123.4% growth in sales in just one year after its partnership with Boryung Pharmaceuticals. Last year, despite the spread of the COVID-19 pandemic, it increased its market share by twofold and raised ₩15 billion in sales. This is a fourfold expansion in annual sales compared to 2018, before signing a partnership with Boryung Pharmaceuticals. And the company is continuing to make new records, earning ₩4.9 billion in Q1, and ₩5.4 billion in Q2. Cumulative sales in 1H of this year were ₩10.2 billion, a 62.8% increase from the previous year. On the other hand, Neulasta sold ₩12.3 billion, a 0.2% decrease from the previous year. This has narrowed the gap between the two products to ₩2.2 billion. If this trend continues, experts believe the position of the two products may be reversed within this year. On the other hand, Dong-A ST’s neutropenia treatment ‘Dulastin, which was released at a similar period as GC Cross’s Neulasta, has still been unable to mark a presence in the market. Dulastin sold ₩1.5 billion in 1H this year. Until 2018, the drug had made sales similar to Neurapeg. However, due to Neurapeg’s sudden and rapid growth in sales, the sales gap has widened to around 7 times. Dong-a ST had received marketing authorization for Dulastin in August 2014, and has started selling it in March of the following year. Dulastin is a second-generation G-CSF derivative that was applied to the company’s own extended-release technology for longer action. Its extended-release technology allows for the drug to stay in the blood for a longer period of time, which allows patients to administer the drug only once per chemotherapy cycle. ‘Lonquex (lipegfilgrastim),’ another second-generation neutropenia treatment that was released in 2016, is also not seen much sales for many years. Longquex sold ₩1.5 billion in 1H this year. This was a 6.2% YOY increase. Lonquex is a molecular structurally improved G-CSF that was developed by applying Handok Teva’s unique PEGylation technology. It is also administered once per chemotherapy cycle.
- Company
- Dong-A strengthens line-up with Sanofi's Actonel sales
- by Aug 31, 2021 06:13am
- Dong-A ST is expected to create synergy with its item Teribone by taking charge of the sale of Sanofi's osteoporosis treatment, Actonel. Dong-A ST will supply Sanofi-Aventis' osteoporosis treatment, Actonel, starting in October. Actonel is a bisphosphonate-based treatment that inhibits bone absorption. Since its launch in 2003, it has ranked 1st and 2nd in market share, but the amount of prescription has been gradually decreasing due to the emergence of new drugs and changes in treatment strategies. It has been out of stock due to issues such as relocation of manufacturing plants. Sanofi stopped supplying Actonel 5mg due to low sales in April, and stopped supplying Actonel 35mg this month. There are Actonel 5mg, 35mg, 150mg and Actonel EC 35mg. Dong-A ST will continue supplying Actonel that Sanofi gave up. Dong-A ST is planning to resupply Actonel from October after changing permission. Dong-A ST is selling Teribone, a bone formation promoter introduced by a Japanese pharmaceutical company. Although it made ￦260 billion in sales in Japan as of 2014, it is not up to ￦2 billion in Korea. Dong-A ST analyzed that Actonel and Teribone will create synergy effects. Although a remarkable new drug has recently been released, bisphonate preparation is still a standard treatment option. "We expect good synergy with the bone absorption inhibitor Actonel and the bone formation promoter Teribone," a company official said.
- Company
- A lawsuit is scheduled to be filed against the price system
- by Nho, Byung Chul Aug 30, 2021 05:55am
- It is expected that a number of domestic and foreign pharmaceutical companies will file an administrative lawsuit to defend the lowering of the drug price due to the change in the drug price system. Due to the revaluation of the drug price system, 475 items will be reduced in batches starting next month, and the annual economic loss of pharmaceutical companies is estimated to be up to 90 billion won. According to the industry, some domestic and foreign pharmaceutical companies are discussing specific measures with large law firms to cope with the loss of drug prices due to changes in the drug price system. A multinational pharmaceutical company is said to have filed an administrative lawsuit against the MOHW or the HIRA through law firm A to respond to the revision of the additional reassessment, which is scheduled to take effect on the 1st of next month. The pharmaceutical company wants to sue the MOHW because it is ineffective to apply for mediation due to all economic losses since the additional system has already been abolished. In the supply negotiations between the NHIS and pharmaceutical companies, there is a provision that fines will be imposed if the supply of the drug is not smooth due to the drug reduction. Many legal experts say, "Even if there is no immediate disposition, the requirements of administrative litigation will be met if economic disadvantages and rights infringement are certain in the future." In particular, the legal community said that there is a possibility of suspension of execution and winning the lawsuit against the original bill. The industry reported the purpose of the lawsuit that ▲ Violation of trust protection principles under the Administrative Act ▲ Significant loss of sales occurred due to the drug reduction, which was linked to a reasonable interpretation. There was a precedent in which the administrative court accepted the suspension of execution of pharmaceutical companies, citing the regulation under the Administrative Procedure Act that "Trust in administrative actions implemented by administrative agencies should be maintained and protected." In addition, clear evidence data of applicants due to drug reductions are expected to play an important role. 70% of originals, 68% of generic and raw materials, and 59.5% of generics have been applied to the system. If the generic is first registered, it will be given a pharmaceutical product for the first year, and if the pharmaceutical company produces the same ingredient product less than three companies, it will be able to maintain the additional product without limitation until more than four companies are registered. The additional period of this month's notice is limited to three years, and the HIRA's judgment extends up to two times a year, effectively up to five years. It seems to be due to the superficial interpretation that "the risk of supply has been extinguished due to the stable supply of medicines for 10 years after the system was implemented." However, the reason for the stable supply of the drug to date was because of the preservation of the drug price. The smooth supply of drugs correlates with drug prices and cost rates. "This revision notice could interfere with the stable supply of medicines," said an official of company A, who is considering a lawsuit. "IThe use of guidelines to cut drug prices up to the relatively low-cost line can be a good alternative so as not to commit the right to lose the opportunity to treat the public."
- Company
- Entry of generics halt Nexavar’s sole lead in liver cancer
- by Kim, Jin-Gu Aug 30, 2021 05:55am
- Product image of Bayer’s hepatocellular carcinoma treatment NexavarNexavar (sorafenib), which had been leading the liver cancer treatment market for over 10 years since its launch, has handed over its lead to ‘Lenvima (lenvatinib)’. This was a combined result of Nexavar’s drug price falling 30% due to the launch of its generics, and the rise in sales of its competitor Lenvima. Nexavar’s position in the liver cancer treatment market is expected to shrink further while competing with its generics as more products awaiting to enter the market. ◆1H sales of Nexavar drop from ₩10.3 billion to ₩5.6 billion… Impact of drug price cut According to the pharmaceutical market research firm IQVIA on the 28th, Bayer’s hepatocellular carcinoma treatment Nexavar recorded ₩5.6 billion in sales in 1H 2021. Compared to the ₩10.3 billion it earned in 1H of the previous year, sales fell 45%. In the same period, sales of Eisai’s Levima increased by 27%, from ₩ 5.7 billion to ₩7.2 billion. With sales of Nexavar plummeting and Lenvima significantly increasing, their shares in the market also changed. This is the first significant change observed in the market in 13 years since Nexavar was first used as a treatment for liver cancer treatment and 3 years since Lenvima was launched in Korea. Bayer had originally launched Nexavar in Korea in 2006 as a treatment for kidney cancer. Then, in 2008, it added the indication for hepatocellular carcinoma. The drug began to make real sales in 2011 after reimbursement was extended to the indication. Nexavar enjoyed exclusivity in the liver cancer treatment market for 10 years until Lenvima's release in 2018, earning over ₩20 billion in sales annually. However, the competition began after Lenvima was approved for reimbursement in 2019. In the beginning, Nexavar overpowered the market because the drug sequentially allows Stivarga and Cabometyx as follow-up treatments. However, Lenvima gradually increased its influence in the market and narrowed the gap with Nexavar with its improved clinical data. In February, Nexavar faced a direct hit, as its insurance ceiling price was cut by 30%. The government reduced Nexavar’s drug price ex officio by 30%, from the original ₩18,560 to ₩12,992, because Hanmi Pharmaceutical successfully launched its generic after overcoming Nexavar's patent. Quarterly sales of Nexavar and Lenvima (Unit: ₩100 mil, Data: IQVIA) ◆Competition intensifies in the market with the entry of Tecentriq and Nexavar generics Also, Nexvar's sales are expected to continue to fall for the time being. First, the drug price will be cut once more in early next year. Korea’s insurance drug price system mandates that the price of an original drug should be reduced by 30% at the time of a generic drug's release, then to 53.55% of the previous price 1 year after the generic is released. In addition, Roche's immuno-oncology treatment Tecentriq (atezolizumab) is about to enter the first-line treatment market for hepatocellular carcinoma. In February of this year, Tecentriq, in combination with Avastin, passed the Health Insurance Review and Assessment Service's Cancer Disease Deliberation Committee as a liver cancer treatment. This means that reimbursement for Tecentriq is imminent. If approved, Tecentriq's entry into the liver cancer treatment market will only further narrow Nexavar's position in the market. Also, generic competitors await Nexavar. Hanmi Pharmaceutical overcame the patent for Nexavar and was approved for its generic Soranib. In the 5 months since release in February, the drug successfully landed ₩200 million in sales. Hanmi Pharm’s period of exclusivity rights expired at the end of July. However, the possibility that competitors from companies such as Kwangdong Pharmaceutical, which is also challenging Nexavar with its own generics, will add on to the competition remains. Kwangdong Pharmaceutical began a bioequivalence test for its generic last year.
- Company
- Cosentyx begins competition in the market
- by Aug 30, 2021 05:54am
- As Interleukin-17 (IL-17) sanctions enter the primary biological formulation benefit range for psoriasis arthritis, they will compete in earnest with TNF-α inhibitors. Cosentyx (Secukinumab) of Novartis expanded health insurance benefits from psoriasis arthritis to primary biological sanctions on the 1st. Cosentyx can be used if it meets certain conditions among active and progressive arthritis patients who are not effective in treating two or more types of DMARDs or who are difficult to treat due to side effects. The condition is for patients with three or more compressed joints and three or more edema joints. Previously, IL-17 regulations were paid only when TNF-α inhibitors were used first and used as secondary biological regulations in patients with insufficient response or difficulty in treatment due to side effects. This expansion allows Cosentyx to be prescribed in a position equivalent to the TNF-α regulation. Of course, it is not easy to compete with TNF-α drugs, which have long been widely used for autoimmune diseases such as psoriasis arthritis. In response, the interleukin formulation was intended to demonstrate superiority with head-to-head clinical trials. EXCEED studies, phase 3 clinical trial of Cosentyx, are typical. The effectiveness and safety of Cosentyx was compared as a control group with the representative TNF-α formulation, Humira (Adalimumab). The main evaluation item is ACA20 at week 52 of treatment, which represents a 20% improvement in arthritis. Clinical results show that the Cosentyx group and the Adalimumab group had a 67% to 62% ACR20 ratio, which resulted in Cosentyx absolute value, but did not satisfy statistical significance (p=0.0719). However, the rate of improvement in Psoriasis symptoms (PASI 90), a secondary evaluation variable, was significantly different from 65% to 43%. We also demonstrated significant improvements in the integrated evaluation variables ACR50 (more than 50% improvement in arthritis) and PASI100 indicators by 31% versus 19%. The percentage of patients who maintained treatment until the 52nd week was 86% to 76%, which was higher in Cosentyx. Shin Ki-chul, a professor of rheumatology at Boramae Hospital, said at a Cosentyx conference on the 25th, "Although ACR20 did not satisfy the statistical significance, it was different in ACR50 and it was more effective in ACR70. Of course, the primary indicator was set to ACR20 and the clinical design." The advantage of Cosentyx, which differentiates itself from conventional TNF formulations, is that it comprehensively treats the major symptoms of psoriasis arthritis. Cosentyx may be a priority consideration, especially in patients with spondylitis. International treatment guidelines have also changed accordingly. GRAPPA (Psoriasis and Psoriasis Arthritis Research and Assessment Group), a renowned international research group, recommends Cosentyx as a primary biological agent in the treatment of psoriasis arthritis, skin psoriasis, hand and toe psoriasis. The EULAR also suggested Cosentyx as the primary biological agent in arthritis and spinal arthritis in late 2019 and stated that it could be preferred over TNF inhibitors when there are related skin symptoms such as psoriasis. "The fact that IL-17 inhibitors are more effective in skin psoriasis than TNF preparations is now somewhat established. In addition, Cosentyx has the advantage of being able to control the dose from 150mg to 300mg. "It is reasonable to consider Cosentyx as the primary biological agent for psoriasis and other symptoms such as psoriasis." Competition with Taltz, which entered the primary benefit range at the same time, is also noteworthy. Paul Thomas, a medical director at Novartis Korea, said, "The study confirmed that Cosentyx is less likely to develop immunogenicity." Humanized antibodies are those that increase the similarity to human antibodies. Furthermore, human antibodies have no animal-derived parts, minimizing immunogenicity. Cosentyx is also attempting to enter primary biological sanctions in ankylosing spondylitis. Park Hye-yoon, executive director of the Novartis Transplant Immunity and Skin Disease Division, said, "We are trying to deliver good news in Korea as Cosentyx is being paid in most major countries such as the U.S., Canada, Japan and Australia under the primary regulation of ankylosing spondylitis."
