Application is based on Phase 2b/3 SELECTION study data with patients with moderately to severely active ulcerative colitis
Mechelen, Belgium;23April 2021;06.01 CET; –Galapagos NV (Euronext & Nasdaq: GLPG) today report that their collaboration partnerGilead Sciences K.K. (“Gilead”) and Eisai Co., Ltd. (“Eisai”)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 (UC).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 have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a biologic agent. This study showed a statistically significant higher proportion of patients treated with filgotinib 200mg once daily achieved clinical remission at week 10 and maintained remission at week 58 compared with placebo. 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 diseases1 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 was 219,685. The annual prevalence rate per 100,000 was 172.9 (192.3 men, 154.5 women).2
Filgotinib is approved and marketed as Jyseleca (200mg and 100mg tablets) in the Europe Union, Great Britain and Japan for the treatment of adults with moderately to severely active rheumatoid arthritis (RA) who have responded inadequately or are intolerant to one