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- 2026-05-18 18:57:47
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- 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.
- Policy
- MFDS requests supplements for porcine islet transplant trial
- by Lee, Tak-Sun Aug 31, 2021 06:14am
- Experts from the Ministry of Food and Drug Safety expressed the opinion that supplementary data is necessary for the clinical trial protocol studying a xenotransplantation product that transplants islet cells isolated from pigs to diabetic patients. With such an opinion issued, it seems that some time would be required before the clinical trial of a xenotransplantation product is conducted. The trial had gained much attention as being the ‘world’s first’ trial on a xenotransplantation product. On the 30th, the Ministry of Food and Drug Safety disclosed the results of the Central Pharmaceutical Affairs Council (CPAC)’s ‘Advisory meeting on the feasibility of the submitted investigator-led clinical trial on a xenotransplantation product’ that was held on the 13th on its webpage. The clinical trial aimed to transplant an islet cell extracted from a pig to a diabetes patient to verify its effect. A trial testing porcine pancreatic islet cells that secrete insulin on monkeys had confirmed the long-term antidiabetic effect of such transplantation, increasing the potential for its effect in humans. However, the CPAC requested data supplementation, saying that a more detailed plan is required for human trials. One committee member who attended the meeting said, “Despite the efforts stated to educate patients on the self-use of Continuous Glucose Monitoring Systems and self-monitoring, the trial subjects need to be clarified to patients who were objectively verified to have low ability to recognize hypoglycemia (develop hypoglycemic coma). I believe the clinical trial may be approved on the premise that the supplementations are made according to the results of the meeting.” Another member said, “Unlike animal studies, a clearer standard and evidence on selecting appropriate subjects and on the safety would be needed for human xenotransplantation studies, considering the risk and safety issues of humans who would need take immunosuppressants for the rest of their life. As of now, the results are not sufficient to recommend trial commencement.” Another member emphasized, “The blood test results alone cannot ensure safety from infection in humans, especially regarding positive porcine endogenous retroviruses (PERVs). Due to negative opinions on the clinical trial commencement, the Central Pharmaceutical Affairs Council collectively determined that supplementary data would be required for the protocol. The CPAC delivered the opinion that the registration criteria and scope should be clarified, and sufficient quality assessment and non-clinical data (cell survival and distribution, etc) that includes evidence on the safety of porcine pancreatic islet cells (PERV, latent infection, etc.) needs to be submitted. Due to this, the world’s first clinical trial using porcine pancreatic islet cells will not be approved soon. In August last year, the Seoul National University’s Xenotransplantation Research Center, Gachon University Gill Medical Center, and GenNBio had submitted an application for an investigator-led clinical trial that transplants a pancreatic islet cell of a gnotobiotic pig to diabetes patients.
- 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.
- Policy
- There is a need to apply the HPV vaccine NIP Men Under 17
- by Lee, Jeong-Hwan Aug 31, 2021 06:13am
- President Moon promises free vaccination for girls under 12 → girls under 17. In addition, there is a need for free vaccination of male teenagers of the same age group. HPV, which causes cervical cancer, claims that the country needs to expand vaccination because it can infect both men and women through sexual contact and causes various diseases such as men's penile cancer, anus cancer, and mouth cancer. Recently, President Moon promised to expand the national vaccination age range of the cervical cancer vaccine Gardasil 9 to women under the age of 17. This means the expansion of Gardasil 9's NIP coverage. The possibility of additional benefit for men under 17 years of age is checked for the effectiveness and side effects of Gardasil 9. The application of the HPV vaccine to men under the age of 17 was necessary when Choi Hye-young, a member of the Democratic Party of Korea, proposed some revisions to the Act on the Prevention and Management of Infectious Diseases in November last year. Representative Choi Hye-young's proposal includes expanding the mandatory vaccination age range for HPV vaccines from "girls under 12" to "all children and adolescents under 18." Cervical cancer is the only cancer vaccinated against 99% or more. However, the vaccination price reached up to ￦600,000, making it difficult to expand the vaccination rate. HPV vaccines are rapidly expanding from vaccinations for women only in the past to those for both men and women today. In fact, the WHO, the ACS, and the NCI have announced plans to raise the vaccination rate of HPV to 80% for young men and women aged 13 to 15. The CDC ACIP and the IPVS are also recommending vaccinations for girls and boys aged 11 to 12. In addition, 40 out of 113 countries in the world that have confirmed the HPV vaccine are supporting the expansion of male vaccinations. Other countries that support vaccination include the United States, Canada, Australia, New Zealand, Switzerland, Italy and Austria. In addition, 35 out of 36 OECD countries introduced HPV vaccine as a national vaccination, and more than half of them expanded their vaccination targets to South Korea. Choi, who proposed the bill, was pleased with President Moon's promise to expand the age of HPV vaccinations, but expressed regret that male teenagers under the age of 17 are not included. Some criticize that most female teenagers under the age of 17 who fall within the national prevention range of HPV vaccine have already received free vaccination benefits from the designation of the NIP in 2016, which is not effective. This is why some point out that free vaccination should be carried out not only for women under the age of 17 but also for men of the same age to increase the effectiveness of NIP. An official from the domestic pharmaceutical industry said, "It will take years for President Moon to expand the application of HPV vaccine NIP." He said, "HPV disease is increasing the prevalence rate of men, so the government should consider a policy to include male adolescents in the scope of NIP." Rep. Choi Hye-young said, "I would like to express my deep appreciation for President Moon's direct response. Cervical cancer is the only cancer that can be prevented by vaccination. However, the free vaccination target was limited to 12-year-old girls, which was not effective enough." She added, "We will conduct legislative activities focusing on the infection prevention law, which has been proposed, including the issue of boys being excluded from the free vaccination list for cervical cancer."
- 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.
- Policy
- Korean pharmas are pursuing various SGLT-2 combos
- by Lee, Tak-Sun Aug 30, 2021 05:55am
- Jeil Pharmaceutical HQ located in Seocho-gu, Seoul Companies are busy developing combination therapies combining the latest diabetes treatment, SGLT-2 inhibitors, with existing diabetes treatment. In particular, domestic companies that are eyeing the SGLT-2 market have been testing various combinations for commercialization. On the 26th, the Ministry of Food and Drug Safety approved the Phase III clinical trial protocol for ‘JT-001’ that was submitted by Jeil Pharmaceutical. The trial will be conducted to assess the safety and efficacy of additionally administering JT-001 in combination with dapagliflozin+metformin in type 2 diabetes patients inadequately controlled by the dapagliflozin+metformin combination. JT-001, or pioglitazone hydrochloride, belongs to a type of existing diabetes drug class called TZD (thiazolidinediones). Therefore, the trial's purpose is to assess the safety and efficacy of administering pioglitazone hydrochloride in combination with dapagliflozin+metformin, to ultimately commercialize the 3-drug combination. Recently, companies have been first identifying the safety and efficacy of their combination drugs through Phase III trials, then conducting bioequivalence tests comparing the combined use of individual ingredients and the combination drug through Phase I trials. The Phase III first then I approach is backward compared to the conventional method where the trials are conducted sequentially, from Phase I to II, then III. This method can be applied because new combination drugs are exempt from Phase II trials, and the Phase I (bioequivalence test), and Phase III (efficacy test) are different in nature. Even when the drug fails to demonstrate bioequivalence in the Phase I trial, the drug may still receive approval if it demonstrates its efficacy in the Phase III trial. Jeil Pharmaceutical’s JT-001 has currently only received approval to conduct the Phase III trial. SGLT-2 inhibitors block the SGLT2 transporter that is in charge of glucose reabsorption and excrete glucose through the urine for an antihyperglycemic effect. Major SGLT-2 drugs are Forxiga, Suglat, and Jardiance. These drugs, which are all new drugs developed by foreign pharmaceutical companies, have been leading the latest diabetes treatment trend. Domestic companies are also busy developing latecomers to join in the SLGT-2 inhibitor market. Some companies, like Daewoong Pharmaceuticals, are pursuing new drug development with new ingredients like enavogliflozin, etc., but most are developing modified or combination drugs using existing ingredients. This is because it is easier to avoid patents with incrementally modified drugs or combination drugs. Like Jeil Pharmaceutical, Chong Kun Dang is also developing an SGLT-2 inhibitor + TZD combination drug. The company is conducting a clinical trial on a combination drug that combines its self-developed TZD class lobeglitazone (brand name: Duvie) with an SGLT-2 class empagliflozin, and metformin. Also, approval for SGLT-2+DPP-4 combination drugs is imminent. Dongkoo Bio&Pharma had applied for the approval of a combination drug combining the SGLT-2 class dapagliflozin with the DPP-4 class sitagliptin to the Ministry of Food and Drug Safety in the first half of this year. As Dongkoo Bio&Pharma developed the drug jointly with other pharmaceutical companies, more products are expected to file for approval. Also, LG Chem is conducting a clinical trial to commercialize its DPP-4 inhibitor gemigliptin and SGLT-2 inhibitor dapagliflozin combination, and Aju Pharm is also conducting the same trial on a linagliptin+dapagliflozin combination Once commercialized, pharmaceutical companies expect a strong performance from the combination drugs as the individual ingredients contained in the drugs are all blockbuster drugs that are commonly used in combination in practice. However, with so many fixed-dose combinations drugs to come, and the preference for originals and combined prescription of individual drugs still strong, whether the performance of the to-be-released combination drugs will be strong remains to be seen.
- Policy
- The patent for Breast Cancer Therapy Affinitor has been clos
- by Lee, Tak-Sun Aug 30, 2021 05:55am
- The patent suit for Affinitor, which was conducted by Novartis and Kwang Dong, was finally closed due to the plaintiff's withdrawal. As a result, Kwang Dong and Samyang Biopharm are able to market more actively. According to the industry on the 26th, the lawsuit against the use patent of Afinitor, which has been filed since March last year due to Novartis' complaint, ended with the withdrawal of the plaintiff's complaint on the 19th. Novartis filed a complaint in January last year asking for cancellation of the Intellectual Property Trial and Appeal Board's claim for invalidation of the Afinitor patent filed by Kwang Dong. Kwang Dong first filed a claim for invalidation of the patent in March 2016, and finally won in about five years. The use patent for Afinitor was due to end in February next year. After is a drug used in anti-cancer drugs such as breast cancer. Sales based on IQVIA last year were ￦14.9 billion. It is currently licensed as generics for Afinitor by Kwang Dong and Samyang Holdings. Kwang Dong's Erinito 10mg was approved in March 2019 and Erinito 5mg in March last year. In July last year, Samyang Holdings' Everose 10 mg, 5 mg and 2.5 mg were licensed As the patent lawsuit is closed, both companies are expected to focus their efforts on product marketing without any burden of patent infringement. Given that there are only three products with the same ingredient, it is expected that sales of generics will increase. On the other hand, Novartis, the original company, is expected to come up with various strategies to check out generic companies.
- 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."
