- LOGIN
- MemberShip
- 2025-12-25 04:43:00
- Company
- Companies reattempt to avoid Dukarb's patent in 2nd trial
- by Kim, Jin-Gu May 09, 2022 06:03am
- Companies that have failed to challenge the patent of Boryung’s antihypertensive combo drug ‘Dukarb (fimasartan+amlodipine)’ are continuing on their challenge with a second trial. As the companies are also working to invalidate the patent apart from the trial being conducted to avoid the patent, this two-track challenge on a single patent is expected to continue on for a while. According to industry sources on the 6th, Arlico Pharm, Hutex Korea Pharmaceutical, Shinpoong Pharm, and Hana Pharm filed an appeal against a ruling to the Patent Court of Korea. In other words, the four companies are taking the matter to the next trial, dissatisfied with the ruling of defeat given to them in the first trial. Around 40 companies are currently challenging Dukarb’s patent and can be divided into 4 groups: One group centered around Arlico Pharm; the DongKoo Bio&Pharma group; the Navipharm group; and the Genuone Sciences group. Since March. the four groups had filed a passive trial to confirm the scope of patent on Dukarb’s combination composition patent, one after another. Only Arlico Pharm’s group received a ruling in the first trial. The Intellectual Property Trial and Appeal Board ruled in favor of the original company, Boryung Pharmaceutical. Although the ruling hasn’t been made yet for the other generic companies, as the IPTAB conventionally makes similar rulings on the same cases, the industry forecasts defeat for the other groups as well. In this situation, the Arlico Pharm and others group has decided to continue its challenge with a second trial, forewarning a prolonged dispute. The other groups that lose their first trial in the future are now also highly likely to continue on their challenge in the second trial, just like Arlico Pharm. Apart from the trial being conducted to avoid Dukarb’s patent, the Arlico Pharm and others group is also attempting to invalidate Dukarb’s patent. In other words, the group is targeting the same patent in two ways (avoidance·invalidation). Other generic companies are also considering filing invalidation trials on Dukarb’s patent. Currently, 27 companies have filed invalidation trials against Dukarb’s patent besides Arlico Pharm. Dukarb’s patent is set to expire in August 2031. If the companies succeed in evading or invalidating the drug’s patent, generic versions of Dukarb can be released early on, as soon as Dukarb’s single-agent ingredient Kanarb’s substance patent expires in February next year. Dukarb is an antihypertensive combination drug that contains the antihypertensive ingredient fimasartan (Kanarb) which was developed by Boryung Pharmaceutical, and amlodipine. According to the market research institution UBIST, Dukarb’s prescriptions recorded ₩41.1 billion last year, a 14% increase YoY compared to the ₩36.1 billion in 2020.
- Company
- GLP-1 diabetes drugs are being released one after another
- by May 09, 2022 06:03am
- Novonodisc is expected to change the market for type 2 diabetes treatment as GLP-1 similarity products are released one after another. Novonodisc received domestic approval for Rybelsus (Semaglutide) on the 2nd following Ozempic on the 28th of last month. Ozempic is a long-lasting injection administered once a week, and Rybelsus is a drug that has changed it to an oral drug. Ozempic is expected to emerge as a strong competitive drug for Eli Lilly Trulicity, which currently dominates the GLP-1 analog market. Trulicity is a injection once a week that monopolizes the GLP-1 similarity market worth 50 billion won in Korea. According to IQVIA, a pharmaceutical market research firm, Trulicity posted 49.9 billion won in sales out of 50 billion won in the total GLP-1 similarity market. Trulicity replaced all GLP-1 analogs that had to be administered daily. Sanofi Lyxumia and AstraZeneca Byetta have been withdrawn from the market. Novonodisc's Viktoza only sold 200 million won. Unlike Trulicity, Ozempic has indications for reducing the risk of cardiovascular events. This indication is based on the SUSTAIN 6 study among Ozempic's eight SUSTAIN clinical studies. As a result of conducting clinical trials on 3,297 type 2 diabetes patients with cardiovascular disease or cardiovascular risk factors, the Ozempic group reduced the risk of major cardiovascular events (MACE) compared to the placebo group by 26%. Not only the United States but also domestic academic societies recommend GLP-1 analogs or SGLT-2 inhibitors that have confirmed cardiovascular benefits when choosing type 2 diabetes drugs, so the Ozempic's sa;es is expected to rise further. The world's first oral GLP-1 analog Rybelsus will then join, and changes are expected in the market for oral diabetes treatments such as DPP-4 inhibitors. Rybelsus can be used as a dietary and exercise supplement to improve blood sugar control in adults with insufficient control of type 2 diabetes. It is taken once a day, and there is no need to control the dosage of drugs in patients with renal or hepatic dysfunction or in the elderly. Oral drugs such as DPP-4 inhibitors and SGLT-2 inhibitors are commonly used as many patients are reluctant to inject injections such as insulin and GLP-1 analogs when treating type 2 diabetes. Based on the drug market research agency UBIST, the amount of DPP-4 inhibitor prescriptions reached 151.2 billion won last year. The prescription amount for SGLT-2 inhibitors is around 40.2 billion won. Rybelsus demonstrated superior glycemic effectiveness over SGLT-2 inhibitors and DPP-4 inhibitors through global clinical study PIONEER. In PIONEER 2, 822 patients with type 2 diabetes whose blood sugar is not controlled by metformin were compared with the SGLT-2 inhibitor Empagliflozin group. At 26 weeks, the Empagliflozin group had a 0.9% decrease in glycated hemoglobin levels, while the Rybelsus group had a 1.3% decrease. Subsequently, in a PIONEER 3 study comparing Rybelsus and DPP-4 inhibitor Sitagliptin in patients whose blood sugar is not controlled by combination administration of Metformin and Sulfonylurea, the glycated hemoglobin level in the control group decreased by only 0.8% at 26 weeks. In the Empagliflozin group, glycated hemoglobin levels decreased by 0.9% compared to the baseline, while in the Rybelsus group, they decreased by 1.3%. Subsequently, in a PIONEER 3 study comparing Rybelsus and DPP-4 inhibitor Sitagliptin in patients whose blood sugar is not controlled by combination administration of Metformin and Sulfonylurea, the glycated hemoglobin level in the control group decreased by only 0.8% at 26 weeks. Even globally, Rybelsus is emerging as an emerging competitive drug. Rybelsus, which was released in more than 20 countries starting with the U.S. in September 2019, posted sales of 867.2 billion won last year. Immediately after its launch, it slowed down due to the COVID-19 pandemic, but it quickly increased sales by aggressive marketing last year. Rybelsus is expected to change depending on the price of Rybelsus and the results of CVOT confirming the ongoing cardiovascular benefits.
- Company
- Sales of Losartan are plummeting due to the impurity crisis
- by Chon, Seung-Hyun May 09, 2022 06:03am
- The prescription market for the hypertension drug "Losartan" has shrunk significantly. It is analyzed that a large number of prescription gaps occurred due to detection of excess impurities at the end of last year. According to UBIST, a pharmaceutical research agency, on the 2nd, the outpatient prescription amount of Losartan-containing drugs in the first quarter was 60 billion won, down 24.4% from the same period last year-on- The prescription market for Losartan drugs rose 20.7% in four years from 65.8 billion won in the first quarter of 2017 to 79.5 billion won in the first quarter of last year, showing a stable upward trend every year. In the third quarter of last year, it formed a market size of 81.2 billion won. However, it fell to 75.7 billion won in the fourth quarter of last year and fell for the second consecutive quarter. The recent sluggish prescription market for Losartan drugs is directly attributed to the impurity wave that erupted last year. The manufacturing numbers of 183 items of 73 items of Irbesartan 3 ingredients were recovered due to the detection of excess impurities. At the end of last year, impurity problems were exposed throughout Losartan products. In December last year, 295 items made by Losartan were voluntarily recovered from 98 companies that were detected in excess of the standard or feared to be detected in excess. As many as 96.4% of 306 items from 99 companies on the market were included in the recall list. At that time, 94 items from a total of 34 companies out of 295 Losartan products were virtually avoided by having available products. Since then, many Losartan drugs have solved the problem of impurities and returned to the market. It is observed that many of the impurities excess detection Losartan formulations have been changed to the same formulation without problems. However, there is a possibility that the prescription may have been changed to other drugs of the same angiotensin II receptor blocker (ARB) as the impurity problem was exposed throughout the Losartan formulation. In the first quarter of last year, the prescription performance of Losartan was 17.4 billion won, down 35.2% from the same period last year. The single Losartan showed a total of 26 billion won in prescriptions from the first quarter to the third quarter of last year. Following a drop of 24 billion won in the fourth quarter of last year, the decline has widened this year. Combination drugs including Losartan had a prescription amount of 42.7 billion won in the first quarter, down 18.9% from the previous year. The Losartan complex has been around 50 billion won since the second quarter of 2019, but it has fallen to 40 billion won in three years. Combination of Losartan+Amlodipine and Combination of Losartan+HCTZ were significantly sluggish. The combination, which combines Losartan and calcium channel blocker (CCB)-based hypertension drug Amlodipine, was 22.2 billion won in the first quarter, down 14.6% from the previous year. The compound of Losartan and diuretic HCTZ shrank 43.8% from 17 billion won in the first quarter of last year to 9.5 billion won in a year.
- Company
- Breast cancer supplement Nerlynx is available in hospitals
- by Eo, Yun-Ho May 06, 2022 05:46am
- Breast cancer supplement Nerlynx has become available in hospitals. According to related industries, Tyrosine kinase inhibitor Nerlynx (Neratinib), which inhibits Bixink's HER2 protein, passed the Drug Committee (DC) of medical institutions such as Seoul National University Hospital. However, as it is still non-reimubrsement, it is expected to take time until Rx is activated. It was submitted to the HIRA's Cancer Disease Review Committee in February, but the standard was not set. Bixink plans to submit an application again in the second half of this year. HER2-positive early breast cancer has a 1.89 times higher risk of epilepsy than HER2-negative breast cancer. The high incidence of brain metastasis is interpreted as having a direct effect on the survival rate. Comparing the 5-year survival rate of metastatic breast cancer in Korea, the 5-year survival rate of patients with epilepsy is only 10.7%, which is a clear difference compared to the 34% 5-year survival rate of patients who have metastasized to other areas. Compared to the past, a number of HER2-positive early breast cancer target treatments have been developed, diversifying treatment options for patients and gradually improving survival rates. However, in the case of current standard therapy treatments, drugs that prevent epilepsy or prove therapeutic effects are still insufficient. In a five-year long-term follow-up study, Nerlynx reduced the risk of recurrence or death in women with HER2-positive early breast cancer by 42% and reduced the risk of developing or death of epilepsy by more than 59%. Nerlynx was originally a drug developed by Puma Biotechnology in the U.S., and was first approved by the U.S. FDA in July 2017 as an extension aid for early HER2 positive breast cancer patients. In February 2020,it was expanded to treat metastatic HER2 positive breast cancer. Bixink introduced Nerlynx in Korea in October last year, and the current indication is "extension therapy for patients with early breast cancer who are positive for HER2 and hormone receptor within one year of completion of Herceptin-based treatment after surgery."
- Company
- Hospitals Busy Introducing Kymriah
- by Moon, sung-ho May 06, 2022 05:45am
- The full-fledged administration of Kymriah, a Korean Novartis CAR-T treatment called an "ultra-high-priced anticancer drug," has begun. Hospitals have also become busy as the administration of treatments at four large hospitals in Korea has begun in earnest. At the beginning of last year's domestic approval, it was a wait-and-see attitude, but as the number of inquiries from patients increased at the same time as the benefit increased, it is eager to complete the facility. According to the medical community, starting with Asan Medical Center in Seoul, Kyungpook National University Hospital, Chonnam National University Hospital, and Pusan National University Hospital are currently undergoing preliminary work for Kymriah administration, focusing on the metropolitan area and national and public university hospitals. At the same time as health insurance was applied in April, there are currently four hospitals that have completed the certification process conducted by the MFDS and Novartis on their own. Specifically, they include Seoul St. Mary's Hospital, SMC, Seoul National University Hospital, and Severance Hospital. Some professors from local university hospitals raised complaints about Novartis' first certification work at only four places, but the controversy subsided as public opinion prevailed that the introduction should not be delayed anymore. The situation has changed since April when Kymriah's benefit was applied. "After Kymriah's domestic approval last year, Novartis first certified four large hospitals, raising equity issues at local university hospitals," said a professor of blood medicine at Seoul National University Hospital, who asked not to be identified. He supported public opinion, saying, "Some professors publicly raised problems by saying that they would introduce CAR-T treatments for other global pharmaceutical companies to be introduced after Kymriah." According to the MOHW, the number of non-Hodgkin lymphoma patients, including DLBCL, in 2017, is counted as 1904 per year. "Last year, the process of collecting patient cells and sending them to Novartis in the United States was not established," said a professor of blood medicine at another local university hospital. It is true that there were complaints as pharmaceutical companies pushed for it from Seoul's mega hospital. We are currently pushing for the introduction of Kymriah, and the full-scale discussion began last November. While full-scale discussions have been underway since this year, we have been in a hurry as we have been reimbursed," he explained. A professor at a local national university hospital, who is promoting the introduction, said, "Since we have certified Kymriah from Seoul's super-large hospital, local hospitals are somewhat late. However, in the second half of the year, more than 13 university hospitals will be able to administer Kymriah, he said. "Novartis also has know-how while signing contracts with hospitals, so it will proceed quickly in the future." "What's worrisome is that CAR-T treatments are being developed in Korea in addition to Kymriah," he said. "The same facility standards should be applied to them, but the evaluation process for the GMP standards of the MFDS is needed." Novartis explained that the university hospital that first introduced Kymriah was comprehensively considered such as the GMP certification situation of the MFDS. An official from Novartis explained, "The hospital approved as a CAR-T center (Kymriah treatment available) is Samsung Medical Center, Seoul National University Hospital, Severance Hospital, and Seoul St. Mary's Hospital, and Asan Medical Center will soon open." He emphasized, "CAR-T treatment is a one-person customized treatment that requires completely new procedures, and various facilities, manpower, and technical aspects should be equipped for approval of the MFDS' management business, including human cells." He added, "The certification process of the four hospitals has been completed and opened as a Kymriah center first, and soon, the center certification will be completed at Asan Medical Center in Seoul with permission for management such as human cells."
- Company
- Risk of Impurities in Treatment of Schizophrenia
- by Chon, Seung-Hyun May 04, 2022 06:04am
- The health authorities have started to check for impurities on Quetiapine-based drugs used as schizophrenia treatments. It is a new type of nitrosamines impurity that has not appeared before. The number of drugs that have raised the risk of impurities in Korea has increased to 10. According to the industry on the 3rd, the MFDS recently ordered pharmaceutical companies to submit data for reviewing impurities N-Nitroso-Aryl Piperazine of Quetiapine-containing drugs. This is a proactive measure based on safety information that NNAP has been detected in Quetiapine recently. The MFDS ordered pharmaceutical companies to submit test results for representative manufacturing numbers among commercially available Quetiapine finished products by July 28. Representative lot numbers refer to more than three units of manufacture that are nearing their use date every year. If three lot numbers or less are produced each year, the test results of all lot numbers shall be submitted. Quetiapine is a drug used to treat schizophrenia, and the original product is Alvogen Korea's Seroquel. Currently, more than 30 domestic pharmaceutical companies are selling generic products. The size of the domestic prescription market is about 30 billion won per year. This is the first time that a risk of impurities has been raised in Quetiapine formulations. NNAP is a nitrosamines impurity that has not been exposed to risks in existing drugs. Since 2018, two types of Nitrosamines impurities, NDMA and NDEA, have been detected in Valsartan, Ranitidine, and Nizatidine. Recently, the MFDS launched an inspection according to safety information that another nitrosamines impurity NDPA was detected in Montelukast, a treatment for asthma and allergic rhinitis. In March, NMOR exceeded the daily intake allowance of drugs containing the vascular reinforcement Flavonoid Fraction ingredient, and voluntary recovery was carried out. Last year, two types of Azido-based impurities were found in Sartan products. As a result, drug impurities triggered by the first NDMA expanded to seven species in four years. Valsartan, Ranitidine, Losartan, Nizatidine, Metformin, following Varenicline, Irbesartan, Montelukast, and Flavonoid, the number of drugs exposed to the risk of impurities increased to nine. Among them, Valsartan, Losartan, Nizatidine, Metformin, Varenicline, and Irbesartan were suspended and recovered from sales of some products, and Ranitidine was expelled. Montelukast has not yet recovered any products due to the detection of excess impurities.
- Company
- Insurance benefit for Vemlidy expanded in Korea
- by May 04, 2022 06:03am
- Pic of Vemlidy tabThe health authorities have extended the insurance benefit of Gilead Science’s chronic hepatitis B treatment ‘Vemlidy (tenofovir ala fenamide)’ to liver cirrhosis and hepatocellular carcinoma, accelerating the generation shift of HBV drugs in Korea. According to the Ministry of Health and Welfare on the 3rd, Vemlidy’s reimbursement standards have been extended starting May 1st for the initial treatment of decompensated cirrhosis and hepatocellular carcinoma patients. In the past, insurance benefit was only provided for patients who had been using Vemlidy for HBV and progressed to liver cirrhosis or hepatocellular carcinoma. With the expansion of the reimbursement benefit, the phrase ‘reimbursement of oral tenofovir ala fenamide is not recognized for decompensated cirrhosis and hepatocellular carcinoma’ in the detailed recognition criteria for oral chronic HBV treatments has been deleted. However, in patients with decompensated cirrhosis, reimbursement is only allowed when the patient has reduced kidney function or osteoporosis. Quarterly prescriptions of Viread, Baraclude, Vemlidy (Unit: ₩100million, Source:UBIST) Vemlidy is a next-generation HBV treatment that Gilead released as a follow-up treatment of ‘Viread (tenofovir).’ The company had improved safety and convenience in intake while maintaining the efficacy of its existing blockbuster HBV treatment Viread. Vemlidy is a novel, targeted prodrug of tenofovir that has demonstrated antiviral efficacy similar to and at a dose less than one-tenth that of Viread. Also, Vemlidy has improved toxicity issues such as the potential risk of nephrotoxicity that arose with the long-term use of Viread. Gilead succeeded in expanding the indication of Vemlidy to liver cirrhosis and end-stage renal disease last year and then succeeded in expanding the scope of reimbursement for the drug this year. By securing the scope of indications for which Viread and Baraclude were previously prescribed, the company was able to seek complete generation change. Also, Vemlidy's share and position in the chronic hepatitis B treatment market continue to grow. According to the market research institution UBIST, prescriptions of Vemlidy rapidly increased from ₩200 million in the first year of its release to ₩7.4 billion in the following year, then to ₩18.9 billion in 2019, and ₩29.7 billion in 2020. Last year, prescriptions of Vemlidy rose 34% from the previous year to reach ₩39.8 billion. Vemlidy is the only product that saw an increase in prescriptions among original hepatitis B drugs last year compared to the previous year. Also, Vemlidy recorded ₩10.5 billion in Q1 this year, up 20% from the same period of the previous year. However still, Viread and BMS’s Baraclude (entecavir) still tops the market as the No.1 and No.2 products, although the gap has narrowed significantly with Vemlidy’s sales continuing to grow while sales of Viread and Baraclude continue to fall. Viread, which had an annual prescription of ₩184.3 billion in 2017, decreased to ₩170.3 billion in 2018 and ₩115.9 billion in 2019 due to the introduction of Vemlidy. Last year, the drug recorded ₩951 billion. Baraclude recorded prescriptions of around ₩77 billion in the same period. One obstacle Vemlidy must overcome to achieve rapid generation change lies in the strict prescription switching standards for HBV drugs in Korea. Unlike other chronic diseases, the standards for switching drugs in HBV are quite strict. Patients should show tolerance or insufficient and non-response to treatment, justifiable decreased adherence, and objectively documented serious adverse reactions to switching their drugs. Serious adverse reactions here include muscle enzyme elevation and neutropenia. Switching drugs without justifiable cause will result in reimbursement cuts, and this is why Viread and Baraclude are maintaining their ₩170 billion prescriptions in the market.
- Company
- Boryung challenges patent for leukemia drug Tasigna
- by Kim, Jin-Gu May 04, 2022 06:03am
- Boryung has challenged Novartis' patent for its leukemia treatment Tasigna (Nilotinib). If the patent avoidance challenge is successful, Boryung is expected to be able to aim for synergy with the previously released Glivec (Imatinib mesilate) generic. According to the pharmaceutical industry on the 3rd, Boryung recently requested a passive confirmation of the scope of rights in all directions on four patents of Tasigna. Tasigna is protected by a total of five patents. These include use patents that expire in November 2030, formulations patents that expire in 2027, crystalline and salt patents that expire in July 2026, and material patents that expire in August 2023. Among them, material patents have been challenged by domestic companies once. In 2015, nine companies, including Navipharm, filed invalid judgments during the extended duration of material patent of Tasigna, but failed to overcome it. Boryung has come up with a strategy to avoid patents other than material patents. If Boryung succeeds in the all-round patent avoidance challenge, generic releases will be possible after August next year when the material patent expires. Tasigna is a Philadelphia chromosomal-positive chronic myeloid leukemia treatment. It is a follow-up to Novartis's other leukemia drug, Glivec. It can be administered to patients who do not show efficacy in Glivec. According to drug market research firm IQVIA, Tasigna's sales were 40.8 billion won last year. Boryung already has Glima, Glivec's generic. Earlier, Boryung won a six-year patent lawsuit against Glivec. The Glivec patent lawsuit, which began in 2013, finally won the Supreme Court in 2019. Boryung released Glima in 2017. Glima has sales of 1 billion won every year. Sales of Glima are the largest among the generics for Glivec. The pharmaceutical industry predicts that synergy between the two drugs will be possible if Boryung secures the second drug, generic for Tasigna, following generic for Glivec.
- Company
- The first oral GLP-1 Novonodisc's Rybelsus was approved
- by May 04, 2022 06:03am
- The world's first oral GLP-1 analog has landed in Korea. Novonodisk announced on the 3rd that it has obtained an item license from the MFDS for oral GLP-1 analog-based type 2 diabetes treatment Rybelsus (Semaglutide). Rybelsus is used as a dietary and exercise therapy supplement to improve blood sugar control in adults who do not have sufficient control of type 2 diabetes. It is taken once a day, and there is no need to control the dosage of drugs in patients with renal or hepatic dysfunction or in the elderly. Rybelsus demonstrated its validity and safety in eight global clinical studies PIONEER. In particular, it showed a superior blood glucose drop effect than the SGLT-2 inhibitor-based Empagliflozin and DPP-4 inhibitor-based Sitagliflozin, which are representative oral treatments. The advantage of weight control compared to Sitagliptin was also confirmed. In a PIONEER2 study of patients whose blood sugar is not controlled by Metformin, the Rybelsus group confirmed a 1.3% decrease in glycated hemoglobin level compared to the baseline, which is superior to -0.9% of the Empagliflozin group. PIONEER9 and PIONEER10 studies have demonstrated efficacy in Asians. This is a clinical trial conducted on 458 patients with type 2 diabetes whose blood sugar is not controlled by administration of oral hypoglycemia alone. In the change in glycated hemoglobin levels at week 52, the Rybelsus-administered group was -1.7%, which was superior to the Dulaglutide-administered group of -1.4%. Rana Azfar Zafar, president of Novonodisk, said, "Rybelsus is expected to establish itself as an innovative treatment option for adult diabetes patients with type 2 based on the incidental benefits of excellent blood sugar drop and weight control identified through large-scale clinical trials."
- Company
- When will the discussion on Dupixent's benefit be concluded?
- by Eo, Yun-Ho May 03, 2022 06:09am
- It does not seem easy for Dupixent, an atopic dermatitis treatment, to expand insurance benefits for children and adolescents. According to related industries, Standard of Sanofi-Aventis Korea's Dupixent 200mg was recently set. It is the first time in about a year since the application for expansion of benefits in March 2021. Dupixent's expansion of atopic dermatitis benefits for children and adolescents took seven months to start consulting experts last year. As it is an expensive new drug and it was not easy to register for the first time, it is judged that discussions on expansion are also difficult. Although detailed indications are different, there is a clear difference in speed compared to JAK inhibitors such as Lilly Korea's Olumiant and Abbvie Korea's Rinvoq, which belatedly submitted applications for expanding atopic benefits. JAK inhibitors are also relatively inexpensive. Both drugs have been paid since this month. Since it is a RSA drug and a separate dose of Dupixent 200mg has been added, it is necessary to go through the cost-effectiveness review process of the HIRA in the future as well as negotiations with the NHIS. It remains to be seen whether Dupixent will be able to reach an agreement with the government and expand child benefits. A company official said, "In the case of patients with severe childhood atopic dermatitis, treatment options with effects and safety information that can be used after local treatments are practically limited. Sanofi will do its best to administer Dupixent to pediatric and adolescent patients as soon as possible." The current standard for Dupixent's health insurance coverage is when all patients with chronic severe atopic dermatitis aged 18 or older with a history of more than 3 years fall under the EASI (Extension Severity Evaluation Index) 23 or higher ▲even after 4 weeks of primary local treatment, the symptoms were not controlled, ▲ if a full-body immunosuppressant is administered for more than 3 months but has no response (more than 50% reduction in EASI) or cannot be used due to side effects, or ▲ before the start of Dupixent administration. This includes the Dupixent 300 mg dose.
