Filgotinib is an investigational, oral, selective JAK1 inhibitor. Currently, the agent is not approved for use as a rheumatoid arthritis treatment anywhere in the world. The results of the FINCH study and other research into filgotinib were recently discussed with the U.S. Food and Drug Administration (FDA). Based on these discussions, Gilead Sciences Inc. is expected to submit a New Drug Application for filgotinib to the FDA sometime this year.1
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In March, the results of a 52-week, randomized, double-blind, activecontrolled, phase 3 FINCH study were announced. This clinical trial was in methotrexate-naive rheumatoid arthritis (RA) patients. It showed filgotinibtreated patients met the primary endpoint, which was the proportion of patients who achieved an ACR20 response.2
At Week 24, patients who received 100 mg of oral filgotinib and 200 mg of oral filgotinib plus methotrexate showed significantly higher ACR20, 50 and 70 responses compared with methotrexate monotherapy. The safety profile of filgotinib was consistent with previous reports. No new safety signals were identified. The ongoing phase 2 MANTA study is assessing the effects of filgotinib on the male reproductive system (e.g., semen parameters) in patients with moderate to severe Crohn’s disease or active ulcerative colitis. This research was also discussed with the FDA.
Michele B. Kaufman, PharmD, BCGP, is a freelance medical writer based in New York City and a pharmacist at New York Presbyterian Lower Manhattan Hospital.
- Gilead Sciences Inc. News release: Gilead announces intent to submit new drug application for filgotinib to U.S. Food and Drug Administration this year. 2019 Jul 1.
- Gilead Sciences Inc. News release: Gilead and Galapagos announce filgotinib meets primary endpoint in the phase 3 FINCH 3 study in methotrexate-naive rheumatoid arthritis patients. 2019 March 28.