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Jyseleca® (Filgotinib) Approved in Japan for Rheumatoid Arthritis
-- Filgotinib Demonstrates Durable Efficacy and Consistent Safety Profile Through 52 Weeks in Clinical Trials -- FOSTER CITY, Calif. & TOKYO--(BUSINESS
About this update from Gilead Sciences, Inc.
[{"type":"text","content":"\n-- Filgotinib Demonstrates Durable Efficacy and Consistent Safety Profile Through 52 Weeks in Clinical Trials --\n\n FOSTER CITY, Calif. & TOKYO--(BUSINESS WIRE)--\nGilead Sciences, Inc. (Nasdaq: GILD) and Eisai Co., Ltd. (Tokyo, Japan) today announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) has granted Gilead K.K. (Tokyo, Japan) regulatory approval of Jyseleca® (filgotinib 200 mg and 100 mg tablets), a once-daily, oral, JAK1 preferential inhibitor for the treatment of rheumatoid arthritis (RA) in patients who have had an inadequate response to conventional therapies, including the prevention of structural joint damage.\nThis press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200924005942/en/\nGilead Japan will hold the marketing authorization of Jyseleca in Japan and will be responsible for product supply of Jyseleca in Japan, while Eisai will be responsible for product distribution of Jyseleca in Japan in RA. The companies will jointly commercialize the medicine to make it available to physicians and patients across Japan.\n\n“Despite progress in the treatment of RA, existing therapies have not enabled many patients to reach the treatment goals recommended in clinical guidelines. There continues to be a need for effective and well-tolerated new treatment options,” said Tsutomu Takeuchi, MD, Professor of Internal Medicine and Chief of Rheumatology at the School of Medicine, Keio University. “Jyseleca is a new JAK inhibitor that, in clinical trials, has demonstrated clinical improvement, low disease activity and clinical remission in a broad patient population, including patients with inadequate response to biologics.”\n\n“RA causes many patients debilitating fatigue and pain that can significantly interfere with their daily lives,” said Yoshiya Tanaka, MD, Professor at First Department of Internal Medicine, University of Occupational and Environmental Health. “It is important to have new treatment options that can offer patients effective symptom control and bring them new hope.”\n\nThe approval in Japan is based on robust clinical trial results from the global FINCH Phase 3 and DARWIN Phase 2 programs. The FINCH and DARWIN programs evaluated Jyseleca in more than 3,500 patients across a range of RA patient populations, including patients new to trea...