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- 2026-03-18 15:06:09
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- Talks on expanding coverage on Tecentriq to start soon
- by Eo, Yun-Ho Feb 19, 2021 06:17am
- An immunotherapy Tecentriq (atezolizumab) is to face the first threshold to expand the National Health Insurance (NHI) reimbursement in treating patients with either triple-negative breast cancer (TNBC) or hepatocellular carcinoma. A pharmaceutical industry source reported the Health Insurance Review and Assessment Service (HIRA) Cancer Deliberation Committee would be convened on Feb. 24 to deliberate Roche Korea’s programmed death-ligand 1 (PD-L1) inhibiting immunotherapy Tecentriq seeking to expand reimbursement on indication to treat patients with TNBC and hepatocellular carcinoma. Last year, Tecentriq, in combination with nanoparticle albumin-bound (nab) paclitaxel, won the South Korean health authority’s approval to treat patients with TNBC as a first-line treatment, and it also earned an approval to treat liver cancer as a first-line treatment through Avastin (bevacizumab) combination therapy. Once it successfully expands its coverage, Tecentriq would be the first immunotherapy option for the two cancer types. However, it is still unknown what decision the Cancer Deliberation Committee would make. Tecentriq’s first reimbursed indication, treating patients with non-small cell lung cancer (NSCLC) as a second-line treatment, was approved by the South Korean government as the company accepted the condition to cover the initial administration cost. However, Roche has not commented if it would take the same condition for the expanded coverage. The two indications barely had any treatment option and an emerging option of an immunotherapy heightened the interest of medical academics. As far as the possibility goes, the TNBC indication would be more likely. Only 12 percent of patients diagnosed with breast cancer are specifically diagnosed with TNBC, and only a half of the particular patient group would consider Tecentriq option (PD-L1 expression rate is over 1 percent). Relatively small patient size would cause less financial burden. Moreover, TNBC is mostly diagnosed in young and socially active patients younger than 40, which causes high socioeconomic cost from faltering labor, productivity and childcare activities. Accordingly, the coverage on Tecentriq combination therapy could favorably contribute in reducing the social cost in long term. To this date, the needs for the treatment in patients specifically with TNBC—reacting negatively on all receptors (estrogen, progesterone and HER2)—have been unmet. In the IMpassion130 trial, the combination of Tecentriq and nab-paclitaxel demonstrated median progression free survival (mPFS) of 7.5 months in first-line treatment of patients with PD-L1 positive metastatic TNBC, and lowered the risk of progression or death by 40 percent compared with nab-paclitaxel alone. In the same patient group, the Tecentriq combination therapy achieved the median overall survival (mOS) at 25.0 months. Professor Im Seock-ah at the oncology department of Seoul National University Hospital said, “The Tecentriq combination therapy demonstrated a meaningful improvement in PFS and mOS longer than two years in patients with metastatic TNBC. We can anticipate the treatment option to be a crucial turning point in treating metastatic TNBC with high unmet medical needs.” Meanwhile, the efficacy of Avastin combination therapy treating patients with hepatocellular carcinoma was confirmed in the IMbrave150 study. The result found the patient group using Tecentriq in combination with Avastin reduced the risk of disease worsening or death by 41 percent, compared with Nexavar (sorafenib) patient group. The Tecentriq plus Avastin therapy was also confirmed superior than Nexavar therapy as the combination therapy group’s mPFS marked 6.8 months, which was significantly longer than Nexavar group’s 4.3 months. The combination therapy has not reached the mOS, but the median value during the monitoring phase was at 8.6 months. Nexavar had mOS of 13.2 months. Also the combination therapy’s response rate at 27 percent doubled Nexavar therapy’s at 12 percent. Professor Kim Doyoung of Gastroenterology Department at Severance Hospital noted, “Beside the OS, the improvements in the response rate and PFS were positive findings. We are glad to have found an immunotherapy option in the liver cancer area that has no other alternative than Nexavar. Hopefully, the drug can meet the highly unmet medical needs in the future.”
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- Meditoxin and Innotox back for sales, but what about safety?
- by Feb 19, 2021 06:17am
- Although the Ministry of Food and Drug Safety (MFDS) ordered a license revocation on Medytox’ botulinum toxin drugs, they would be back on the shelf and available for sales as the court halts the administrative action. The relevant industry insiders are pointing out MFDS should be more thorough with pre-sales lot release approval for the people’s health and safety. In late 2019, MFDS ordered the company to shorten the expiration date due to safety issues, and imposed an item approval revocation on Meditoxin in June 2020, when it was found to have used unapproved ingredient and manipulated submitted national lot release review material. The ministry also revoked the license on a liquid type botulinum toxin Innotox in last January, because of safety validation evidence. But regardless of the order, Medytox can still sell these drugs now. The court accepted the company’s request for the administrative order suspension. The Daejeon District Court halted the administrative order until the 30th day from the day the decision is made. A biologic drug, botulinum toxin has to receive MFDS’ national lot release approval before selling. The approval is reviewed to ensure safety and efficacy in each lot of the biologic drug, which should be strictly managed to avoid contamination. As the national lot release review is conducted immediately after manufacturing and before distributed to the market, the review cannot ensure the product’s safety exposed to a risk during the destruction process. Especially if the safety evidence was manipulated, the product’s safety cannot be ensured until which point, and consumers would be clueless as to when the product to be administered to a patient is manufactured. A pharmaceutical and bio industry insider expressed concern and commented, “The court reportedly decided to suspend the administrative order to prevent the company from unrecoverable damage. But if the product, before fixing its safety issue, gets distributed, unexpected adverse reaction could happen.” Also there is an issue of fairness. Kolon Life Science’ Invossa had its license revoked due to suspected evidence manipulation, and the court refused to accept the company’s request to suspend the administrative order due to potential risk in safety. Since the Invossa incident, MFDS firmly stated there would be no tolerance for such evidence manipulation, and the ministry reconsolidated the principle with Meditoxin incident. Another industry insider noted, “The court’s decision to suspend the administrative order does not assure safety. MFDS needs to stringently review products to meet the objective of the national lot release review and to assure safety in the people.”
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- 19 Korean companies to challenge Entresto patent
- by Kim, Jin-Gu Feb 18, 2021 06:25am
- A series of South Korean pharmaceutical companies are challenging the patents on Novartis’ heart medicine Entresto (sacubitril, valsartan plus sodium salt hydrate complex). Starting with Elyson Pharm filing a patent trial as a first in last year, 18 other companies expressed their intention to release their generics early. According to a pharmaceutical industry source on Feb. 16, South Korean pharmaceutical companies like CTC Bio, Boryung Pharmaceutical, Yuyu Pharma, Corepharm Bio, Kyperion, MFC, Sinil Pharmaceutical, Daewon Pharmaceutical, Yooyoung Pharmaceutical, Hana Pharm, Hanlim Pharm, Ahn-gook Pharm, Hanmi Pharmaceutical, Chong Gun Dang, Daewoong Pharmaceutical, Genuonesciences, Samjin Pharmaceutical and Kolmar Pharma submitted a patent trial request from Feb. 9 through 15 and joined the race to challenge Entresto patent. Same as Elyson Pharm that started the process earlier, the group of South Korean pharmaceutical companies have filed a negative scope confirmation on Entresto’s crystalline form patent. Currently, total four patents are listed under Entresto brand. Aside from the crystalline form patent to be expired on Sept. 21, 2027, the drug has a product patent expiring in July 2027 and two composition patents expiring January 2029. For an early release of the Entresto generic, the group of South Korean companies would have to also overcome other outstanding patents. By successfully evading the four patents, the follow-on drug companies would be able to launch their generics after April 13, 2022, when the original drug’s post-marketing surveillance (PMS) ends. Norvatis released Entresto, a hard-to-treat heart failure drug, in the South Korean market in October 2017. In the first year of launch in 2018, the drug generated 6.3 billion won from outpatient prescription, and the sales tripled in just two years in last year making 20.3 billion won. South Korean companies have been highly interested in such profitable market for their Entresto generics. Some companies have reportedly initiated bioequivalence test. A pharmaceutical industry associate told, “As Elyson Pharm challenged Entresto patent first, other companies planning to release generics early are also trying to overcome the patent.”
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- SK Bioscience has signed a technology transfer contract
- by Kim, Jin-Gu Feb 18, 2021 06:24am
- SK Bioscience has secured the right to independently produce it in Korea by transferring the technology of Novavax vaccine. SK Bioscience announced on the 16th that it has licensed NVX-CoV2373 and signed a contract with the KCDA to supply 40 million doses of vaccine respectively. SK Bioscience announced on the 16th that it has signed a technology transfer (License In) contract with Novavax for COVID-19 vaccine NVX-CoV2373, and 40 million dose vaccine supply contract with the KCDA. SK Bioscience signed a CDMO (Contract Development & Manufacturing Orgainzation) contract with Novavax in August last year. Since then, it has completed the transfer of vaccine manufacturing and process technology and is conducting commercial production for global supply. It is expected that the domestic supply through this contract will be able to start production immediately. Novavax vaccine uses a synthetic coronavirus spike protein to teach the immune system to produce antibodies that can deactivate the coronavirus. It has proven its long-term safety and effectiveness by being used in existing vaccines such as flu, hepatitis B, and cervical cancer vaccines. Unlike mRNA vaccines that are managed at a cryogenic temperature of -20 to -70°C, this vaccine can be stored refrigerated at 2 to 8°C, so it can be distributed using the existing vaccine distribution network. Recently, the clinical results of Novavax vaccine have been published. Novavax announced last month that Phase III clinical trial of NVX-CoV2373 conducted in the UK in 15,000 adults aged 18 to 84 showed an average of 89.3% preventive effect. The original COVID-19 that did not mutate was 95.6% more effective than the mRNA vaccine, which is considered to be the most effective. For the UK mutant virus and the South African mutant virus, the first vaccines currently under development were confirmed to be 85.6% and 60% respectively. Stanley C. Erck, CEO of NovaVax, said, "We are pleased to expand the partnership we have established for the global supply of NVX-CoV2373 with this agreement." He said, "We are sharing the urgent need to provide a safe and effective COVID-19 vaccine to humanity around the world, including Korea." Ahn Jae-yong, CEO of SK Bioscience, said, "It is of great significance that we have taken the initiative to overcome the pandemic at the national level by securing the technology itself, not simply by purchasing products." He said, "We will work with the government so that our people can get COVID-19 vaccine quickly."
- Company
- Does Propecia cause depression?
- by Eo, Yun-Ho Feb 17, 2021 05:40am
- It has already been reflected in the package insert such as Korea and Europe, and has not been directly proven to have a causal relationship. There was another controversy that the hair loss drug Propecia causes depression. Reuters reported on the 3rd (local time) of the lawsuit filed in the Brooklyn Federal Court of New York in connection with the side effects of Propecia. Since 2009, more than 200 cases of depression among people taking Propecia (Finasteride) have been received, and the developer MSD (Merck, USA) has covered up this. After the report, numerous Korean media spread the content, and in fact, there were even reports that Propecia could cause depression and suicide. This is an exaggeration. Prediction causes controversy, and controversy distorts facts. No one can define as 'true' in the current situation. The issue is whether MSD has concealed the reported adverse reaction cases and prevented the information from being reflected in US permits. Reports of abnormal cases cannot prove a causal relationship with the product. It cannot be concluded that the drug is the cause of the adverse event because an abnormal event has occurred after taking the drug. Brigham and Women's Hospital in US, for example, published an analysis that suggests that Propecia, a mechanism that inhibits the enzyme, may be associated with depression, based on the low levels of Allopregnanolone produced by the 5-alpha-reductase in male depressed patients. In a study published in the Dominican Republic of genetically followed patients with 5-alpha-reductase type 2 deficiency, there was also a study finding that there was no significant difference in depression or suicide frequency between the general population and the corresponding patient group. Kwang-sung Choi, chairman of Korean Hair Research Society (Professor of Dermatology at Inha University Hospital) said, "The reports of adverse reactions from Propecia mentioned in foreign news articles are the cumulative number of voluntary reports related to depression that occurred around the world for about 10 years since its launch in the US in 1998." He said, “Adverse reactions such as depression or suicide risk can be complexed by social, psychological, and economic factors in addition to medical factors. Depression-related cases that have occurred to date are simply those that occurred while taking drugs or were reported voluntarily.” So, did MSD really 'cover up' the facts? It is an obligation, not an option, for pharmaceutical companies to collect and report adverse events after obtaining marketing approval from health authorities and distributing them. The WHO's global adverse reaction database,'VigiBase', has already reported cases of Propecia's depression and mood swings. As mentioned by Reuters, cases of adverse reactions reported in Europe and Canada are already reflected in licenses and product manuals, and the MFDS also inserted the phrase 'depression and mood swings including suicide thoughts' in 2017. No country has stipulated that Propecia causes depression or mood swings. Taken together, it means that MSD has only concealed the phrase inserted in the permits already reflected in many countries in the US. It is also a drug that has been prescribed for over 20 years. Rather than taking the side of MSD, if it intentionally conceals facts, its morality should be blamed. In Korea, many people with hair loss are taking Propecia and are trembling with anxiety over this controversy. Chairman Kwang-Sung Choi said, "Propecia is a Rx drug. Hair loss diseases can be effectively and safely treated by treatment and prescription by specialists, and side effects are also managed through treatment. It is more damaging to stop hair loss treatment or receive the wrong treatment due to excessive fear of side effects or unproven claims.”
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- SK Chemicals sells Janssen’s Ultracet
- by Lee, Seok-Jun Feb 17, 2021 05:39am
- SK Chemicals announced on the 15th that it has signed a domestic sales contract with Janssen Korea for the anti-pain inflammatory drug Ultracet (Acetaminophen/ Trimadol HCl). According to this agreement, SK Chemicals is in charge of Ultracet distribution ,domestic marketing and sales. Janssen Korea will be in charge of production. There are 4 types of products (Ultracet, Ultracet Semi, Ultracet ER, and Ultracet ER Semi). The sales agreement between the two companies is the second following the 2019 dementia treatment Reminyl. Ultracet is one of the most widely used pain relievers in the world since it was first developed in 2002. Ultracet has a broad pain spectrum ranging from moderate to severe pain. There is no need to worry about side effects such as addiction or drug abuse because there are no narcotics that were included in many effective pain relievers. SK chemicals is co-promoting its natural drug No. 1 Joins, which is recording ₩40 billion in sales in the area of pain, and Lilly's Cymbalta (Duloxetine HCl) in Korea, thus establishing a portfolio of analgesic anti-inflammatory drugs.
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- RRMS, actively expanding coverage of drugs
- by Eo, Yun-Ho Feb 16, 2021 06:07am
- There is news of expanding coverage of oral RRMS (Relapsing-remitting multiple sclerosis) drugs. According to industry sources on the 8th, after Mavenclad (Cladribine, Merck) was listed in insurance benefits in the second half of last year, Sanofi Genzyme's primary drug Aubagio was expanded from February. In the case of Aubagio, additional benefits are applied to patients with Relapsing-Remitting Multiple Sclerosis (RRMS) who meet McDonald's diagnostic criteria through examination by a neurologist and who can go to the outpatient clinic. The key to the expansion of this benefit standard is to be able to follow the judgment of experts based on the McDonald standard diagnosis of multiple sclerosis. Aubagio's provisions that only benefit from having two or more neurological dysfunctions in the past two years have been deleted, so that patients with multiple sclerosis can benefit from Aubagio early, and access to treatment is expected to improve significantly. Mavenclad, which is recently prescribed in general hospitals, is the first to show a significant effect in terms of the progression of physical disorders, annual recurrence rate, number of active lesions shown on MRI (magnetic resonance imaging), and major disease activity indicators of RRMS patients. As a short-term oral treatment, it is taken twice for 2 years. The drug's clinical trial program included long-term follow-up data from the 8-year prospective observation registry PREMIERE study, as well as the CLARITY Phase 3 study and CLARITY EXTENSION, ORACLE MS, and ONWARD Phase 2 study corresponding to the CLARITY extended clinical trial. As a result of post-hoc analysis of patients with high disease activity in the CLARITY 2,3 study conducted for two years, the annual recurrence rate of patients receiving Mavenclad decreased by 67%, and the Extended Disability Status Scale (EDSS), which indicates the degree of disability progression. Also, the Mavenclad treatment group showed a 82% decrease compared to the control group. However, when Mavenclad is administered, lymphopenia and shingles can occur as significant adverse reactions. Therefore, patients with multiple sclerosis must measure their lymphocyte counts before and during Mavenclad administration. Mavenclad administration is contraindicated in certain populations, including patients with impaired immune function and pregnant women. A KSNI official said, "The data showed that the sales of oral drugs were far superior to those of injections in just one year. As such, patients would have chosen oral drugs in many cases."
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- Generics for Xeljanz are being approved one after another
- by Kim, Jin-Gu Feb 10, 2021 06:05am
- Xeljanz Generics for Xeljanz (Tofacitinib) are being approved one after another. After crystalline form patent was deleted from the list, it seems that domestic companies are competitively receiving generic licenses. According to the MFDS on the 9th, until this day, a total of 42 generics for Xeljanz have been licensed. Since Boryung's generic was first approved in August of last year, it has continued steadily. Generics have increased rapidly since last December. After GL Pharma on December 23, in about a month or two, 31 companies were granted generic licenses. About half of these are companies that commissioned production to Boryung. Boryung plans to consign products from 16 companies including Korea Prime at Ansan Plant 1. Xeljanz has product patent that expires in November 2025 and crystalline form patent that expires in November 2027. Many domestic companies have challenged the patent. The challenge for crystalline form patent developed in two tracks. 20 companies, mainly Chong Kun Dang, requested an invalidation trial, and 16 companies, including Boryung, requested a passive trial to confirm the scope of rights. In January 2018, as a result of a trial for the passive scope of rights, generics succeeded in evading patent for Xeljanz. The result of the invalidation trial was also won by generics in November 2019. This decision was confirmed in January 2020. Following the decision of invalidation, crystalline form patent for Gelzanz was deleted in March last year. The barrier to the Crystalline Form Patent, which expires in November 2027, has disappeared. Companies that have succeeded in developing generics will be able to release generics after November 2025, when the product patent expires. Considering that there are more than four years left until the expiration of the product patent, there is a high possibility that generic licenses from other pharmaceutical companies will be added. Xeljanz is a JAK inhibitor family of autoimmune diseases. It is released as an oral preparation in the autoimmune disease treatment market, which is mostly an injection, and has overcome the limitations of existing TNF alpha inhibitors. According to UBIST, the amount of outpatient prescriptions last year was ₩12.6 billion. Since its launch in the domestic market in July 2015, Xeljanz has rapidly increased its prescription performance to ₩1.7 billion in 2016, ₩3.3 billion in 2017, ₩8.3 billion in 2018, and ₩12.6 billion in 2019. However, compared to 2019, in 2020, it was stagnant, and this is analyzed due to the addition of Olumiant (Baricitinib) from Lilly. And, no domestic companies have challenged patent of Olumiant.
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- Despite COVID-19 and NDMA metformin prescription surges
- by Chon, Seung-Hyun Feb 10, 2021 06:04am
- Metformin-based antidiabetic drugs showed exceptional growth in the prescription drug market. Both metformin combination and single agent drugs expanded their prescription volume and maintained the credibility in the clinical scene, regardless of the novel coronavirus disease (COVID-19) outbreak and impurity contamination incident. On Feb. 9, a pharmaceutical market research firm UBIST told the outpatient prescription volume in metformin last year marked 535.7 billion won growing 9.5 percent from the previous year. The year 2019 showed a growth of 7.3 percent. Metformin, a type of biguanides, is used vastly on Type 2 diabetic patients as a first-line treatment to control the blood sugar level. Amid COVID-19 pandemic last year, the general prescription drug market fluctuated but the metformin market growth surged. Both metformin and single agent drugs showed definite growth. In last year, metformin single agent drug generated 77.3 billion won, showing a 4.1-percent growth compared to the year before. The growth was increased steeply compared to 2.9 percent growth made in 2019. Meanwhile, the metformin combination drug market had even higher growth. The last year’s metformin combination drug prescription volume grew by 10.5 percent from the year before and made 458.4 billion won. In 2019, the volume grew 8.2 percent compared to previous year. The combination drug market surged by 96.8 percent throughout five years from 2015 making 232.9 billion won. Currently, there are metformin drugs combined with dipeptidyl peptidase 4 (DPP-4) inhibitors, sulfonylureas, glitazone and sodium-glucose co-transporter-2 (SGLT2) inhibitors available in the South Korean market. Among all combination drugs, DPP-4 inhibitor plus metformin drug market had a notable growth. In last year, the DPP-4 inhibitor plus metformin drug prescription volume generated 380.5 billion won, growing by 5.8 percent compared to the year before. In five years from 2015, the market expanded exponentially by 90.5 percent. The DPP-4 inhibitor plus metformin drugs dominates 71.3 percent of the metformin combination drug market share. The SGLT-2 inhibitor plus metformin drug prescription volume also surged by 59.1 percent in last year and made 44.4 billion won. Although metformin drug market suffered a detrimental hit by the impurity contamination, the prescription market firmly consolidated its ground. South Korea’s Ministry of Food and Drug Safety (MFDS) ordered temporary manufacturing and sales suspension and prescription limitation on 31 metformin active pharmaceutical ingredient and complete products supplied in South Korea, as the ministry discovered unacceptable level of N-Nitrosodimethylamine (NDMA) carcinogen in the drugs. The sales ban was imposed on JW Pharmaceutical’s Guardmet, Hanall Biopharma’s Glucodaun OR Tablet and Hutecs Korea Pharmaceutical’s Gluless-M. The order was issued six months after the Singaporean health authority raised an issue of metformin impurity contamination. In December 2019, Singapore’s Health Sciences Authority (HSA) investigated 46 metformin-contained items on sale and recalled three items as they found NDMA exceeding the acceptable daily intake level. Since then, MFDS also started investigating metformin ingredients and complete products in South Korea. The relevant industry was concerned when the South Korean health authority initiated the investigation as it could affect the metformin prescription market. In fact, an anti-hypertension drug valsartan was also found with unacceptable level of impurity and the general market was impacted by the authority’s sales ban order. In July and August 2018, MFDS banned the sales of 175 valsartan single agent drugs and combination drugs using ingredients found with NDMA. Valsartan containing anti-hypertension treatments generated 381.9 billion won in 2017, but the volume continued to slip for two consecutive years in 2018 and 2019 at 376.4 billion won and 332 billion won, respectively. But in last year, the volume increased by 4.0 percent compared to 2019 making a positive growth after three years. Metformin is the only oral antidiabetic drug used for first-line treatment. Basically, the absence of alternative option has protected the drug’s credibility against the impurity incident. Also the sales ban on metformin drugs was limited compared to the overall market. MFDS reported the 31 items banned from sales generated production volume of 22.8 billion won in 2019. It was only 6 percent of the overall production and import volume. And other plenty of options were available, besides the banned items, for the prescription market to have avoided confusion. The industry evaluates the previous experiences of impurity contamination in valsartan, ranitidine and nizatidine have taught the market such incident’s risk is insignificant. When announcing the list of impurity-contaminated metformin items to be banned, MFDS concluded “The harmful risk on human body by long-term exposure to drugs found with unacceptable level of NDMA is miniscule.”
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- More options for ankylosing spondylitis including Taltz
- by Feb 09, 2021 06:04am
- The interleukin 17A (IL-17A) inhibitor drugs are taking over the spotlight in the ankylosing spondylitis treatment market. Besides the first-in-class Cosentyx (secukinumab), Taltz (ixekizumab) was released to the South Korean market with its strong evidences. Some specialists predict the guideline, initially recommending the drug to be used after using tumor necrosis factor-alfa (TNF-α) inhibitor, could be changed. One of the most frequently diagnosed rheumatic diseases, ankylosing spondylitis mostly uses a nonsteroidal anti-inflammatory drug (NSAID). But a biologic drug is recommended for patients with high disease activity. Humira (adalimumab) and Remicade (infliximab) are TNF-α inhibitors, a most commonly used biologic treatment type. Although the drugs are recommended first with their credible amount of clinical data, 30 percent of the patients apparently do not respond to TNF-α inhibitor. Professor Hong Seung-jae at Kyung Hee University Medical Center (Department of Rheumatology) says only one out of three patients maintain the treatment, two years after using biologic treatment. 40 percent of the patients suspend the treatment before starting the second cycle, because of insufficient efficacy. And now IL-17A inhibitors are emerging as a new option. 16 years after a first TNF-α inhibitor was approved, Novartis’ Cosentyx was released as a new drug to treat patients with ankylosing spondylitis. And Eli Lilly’s Taltz followed with a same indication, and joined the competition in the South Korean market as received the National Health Insurance (NHI) reimbursement in last October. Taltz’s strengths in treating ankylosing spondylitis are exceptional level of efficacy and safety. To confirm the efficacy and safety in treating the disease, the COAST-V study had patients who are biologic disease-modifying antirheumatic drug (bDMARD)-naïve, and the COAST-W study had patients who previously had an inadequate response or were intolerant to TNF inhibitors. Both studies chose more stringent primary endpoint, unlike other preceding clinical trials on ankylosing spondylitis, which was the Assessment of Spondyloarthritis International Society 40 (ASAS40) response showing over 40 percent improvement in the patients’ symptoms. The trials were the only and first studies to have set ASAS40 as a primary endpoint. Patients achieving ASAS40 at week 16 The Taltz group in two studies achieved 48 percent and 25 percent of the ASAS40 response at week 16, respectively, and 53 percent and 34 percent at week 52. The results indicated statistically meaningful improvement compared to the placebo group. Taltz also resulted in statistically significant outcome in secondary endpoints—objective signs of inflammation as indicated by elevated C-reactive protein (CRP) and/or magnetic resonance imaging (MRI), as well as patient-reported outcome (PRO). And a head-to-head COAST-V study compared the drug against a TNF-α inhibitor Humira, frequently used to treat patients with ankylosing spondylitis. Ultimately, the Taltz patient group showed higher response rate compared to the Humira patient group. Moreover, Taltz has notable safety profile. A TNF-α inhibitor is banned on patients with severe heart failure, whereas Taltz can be used regardless of the underlying condition. Professor Hong Seung-jae elaborated, “Once-biweekly administered Taltz is more convenient than other once-weekly drugs, and it is known for its high ASAS40 response proving the efficacy. And because it does not have the safety issue the TNF-α inhibitors, the drug can be administered to patients with heart failure.” When the clinical records of Taltz accumulate in the future, the professor thinks the reimbursement and treatment guideline can be easily changed. Currently, Taltz is indicated for use in both first and second-line treatment, but the NHI reimbursement is granted only for using when a patent shows no response to a TNF-α inhibitor. Also, the guideline by the Assessment of SpondyloArthritis International Society/ European League against Rheumatism (ASAS/EULAR) recommends using TNF-α inhibitor with more extensive clinical data, and then recommends an IL-17A inhibitor if the patient does not react to the TNF-α inhibitor. Professor Hong expressed his anticipation in the prospective changes in the reimbursement standards, and said “The healthcare reimbursement standard and overseas guideline categorize the drug as a second-line treatment, as it lacks sufficient amount of clinical data in South Korea. But the data is accumulating globally, and some experts claim the drug should be used at a same level with TNF-α inhibitor.” Meanwhile, relevant experts project other biologic treatment could become a variable in the expansion of an IL-17A inhibitors in the ankylosing spondylitis treatment market. Currently, various Janus kinase inhibitors, such as tofacitinib and upadacitinib, are in process of conducting clinical trials targeting ankylosing spondylitis. Specifically, upadacitinib (brand name Rinvoq) was indicated in EU to treat patients with ankylosing spondylitis, showing off its intention to join the scene. Unlike other biologic treatments, orally taken JAK inhibitor could be preferred more.
