GLPG - Gilead Galapagos' Jyseleca gets approval in Japan for expanded use in ulcerative colitis

The Japanese Ministry of Health, Labour and Welfare (MHLW) approved Gilead Sciences (NASDAQ:GILD), Galapagos (NASDAQ:GLPG) and Eisai's (OTCPK:ESALF) drug Jyseleca (filgotinib) to treat patients with moderate-to-severe active ulcerative colitis (UC), an inflammatory bowel disease. Jyseleca is already approved in Japan to treat rheumatoid arthritis (RA), including prevention of structural joint damage, in patients who had inadequate response to conventional therapies. The approval of the second indication for Jyseleca in Japan was backed by data from a phase 2b/3 trial, dubbed SELECTION. Galapagos is responsible for the commercialization of filgotinib in Europe, while Gilead remains responsible for filgotinib outside Europe, including in Japan, where filgotinib is co-marketed with Eisai (OTCPK:ESALY).

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Gilead, Galapagos' Jyseleca gets approval in Japan for expanded use in ulcerative colitis