Application is Based on Phase 2b/3 SELECTION Study Data with Patients with Moderately to Severely Active Ulcerative Colitis
TOKYO, Apr 23, 2021 - (JCN Newswire) - Gilead Sciences K.K. and Eisai Co., Ltd. today announced that Gilead submitted an application to Japan's Pharmaceuticals and Medical Devices Agency (PMDA) for approval of filgotinib for an additional indication to treat patients with moderately to severely active ulcerative colitis. Filgotinib is a new oral Janus kinase (JAK) inhibitor approved in Japan in September 2020 for the treatment of rheumatoid arthritis.
This latest regulatory submission is based on data from the randomized, double-blind, placebo-controlled Phase 2b/3 SELECTION study evaluating the efficacy and safety of filgotinib for the induction and maintenance of remission in patients with moderately to severely active ulcerative colitis who are biologic-naive or who have used a biologic. This study showed the efficacy and tolerability of filgotinib 200 mg once daily, and no new safety risks were identified.
Ulcerative colitis is a chronic disease characterized by inflammation of the lining of the mucosa of the colon and rectum. The prevalence of ulcerative colitis has been increasing in recent years, and it has a significant impact on the quality of life of more than 2 million people around the world. Even with treatment, defecation urgency, incontinence, recurrent bloody diarrhea, frequent bowel movements, abdominal pain, insomnia and fatigue are common. Ulcerative colitis is one of the intractable diseases designated by the Ministry of Health, Labour and Welfare in Japan. According to a nationwide survey, the estimated number of patients with ulcerative colitis in Japan in 2014 is 219,685, and the annual prevalence is reported to be 100,000 vs. 172.9 (192.3 men, 154.5 women).*
*Murakami Y, Nishiwaki Y, Oba MS, Asakura K, Ohfuji S, Fukushima W, et al. Estimated prevalence of ulcerative colitis and Crohn's disease in Japan in 2014: an analysis of a nationwide survey. J Gastroenterol 2019;54 (12):1070-7
Filgotinib is approved in Japan is for the treatment of rheumatoid arthritis, including prevention of structural joint damage, in patients who have had an inadequate response to conventional therapies. Filgotinib is approved in the Europe Union and Great Britain for the treatment of adults with moderately to severely active rheumatoid arthritis who have responded inadequately or are intolerant to one or more disease modifying anti-rheumatic drugs (DMARDs). Applications have been submitted to the European Medicines Agency (EMA) and the Medicines and Healthcare products Regulatory Agency (MHRA) for an additional indication for the treatment of adults with moderately to severely active ulcerative colitis who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a biologic agent and are currently under review. Filgotinib is not approved in any other countries.
About Gilead Sciences
Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.
Eisai Co., Ltd. is a leading global research and development-based pharmaceutical company headquartered in Japan. We define our corporate mission as "giving first thought to patients and their families and to increasing the benefits health care provides," which we call our human health care (hhc) philosophy. With approximately 10,000 employees working across our global network of R&D facilities, manufacturing sites and marketing subsidiaries, we strive to realize our hhc philosophy by delivering innovative products to address unmet medical needs, with a particular focus in our strategic areas of Neurology and Oncology. As a global pharmaceutical company, our mission extends to patients around the world through our investment and participation in partnership-based initiatives to improve access to medicines in developing and emerging countries.
For more information about Eisai Co., Ltd., please visit https://www.eisai.co.jp.
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