Gilead Sciences, Inc.and Galapagos NV announced 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 supported by data from the Phase III FINCH and Phase II 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)<2.6. Filgotinib also inhibited the progression of structural joint damage assessed by modified total Sharp score (mTSS) compared with placebo.
Across the FINCH and DARWIN trials, once-daily filgotinib demonstrated a consistent clinical safety profile when administered as monotherapy or in combination with methotrexate (MTX). Rates of serious infections and herpes zoster were generally similar to adalimumab and MTX, while rates of major adverse cardiac events (MACE) and venous thromboembolism (VTE) were infrequently reported.
The CHMP positive opinion is a scientific recommendation to the European Commission to grant marketing authorization in Europe.
Jyseleca has a PDUFA date for FDA decision on 19 August 2020.