FOSTER CITY - Gilead Sciences, Inc. (Nasdaq: GILD) and Galapagos NV (Euronext & Nasdaq: GLPG) announced today the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for Jyseleca (filgotinib 200 mg and 100 mg tablets), an investigational, once-daily, oral, selective JAK1 inhibitor for the treatment of adults with moderate to severe rheumatoid arthritis (RA) who have responded inadequately or are intolerant to one or more disease modifying anti-rheumatic drugs (DMARDs).

The CHMP positive opinion is a scientific recommendation to the European Commission to grant marketing authorization in Europe.

The CHMP positive opinion is supported by data from the Phase 3 FINCH and Phase 2 DARWIN programs, which included 4,544 RA patient-years of experience with filgotinib. All three FINCH trials, involving a broad range of patients, met their primary endpoints.In the trials, filgotinib consistently achieved ACR20/50/70 and other relevant treatment targets, such as DAS28(CRP)

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