Dec 19, 2019: Galapagos NV Â announced that its collaboration partner, Gilead Sciences,) has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for filgotinib, an investigational, oral, selective JAK1 inhibitor for the treatment of adult patients living with moderate-to-severe rheumatoid arthritis (RA).
A priority review voucher was submitted with the NDA, shortening the probable time for review. The NDA filing is supported by 52-week data from the global Phase 3 FINCH clinical program, which evaluated the efficiency and safety of filgotinib in 3,452 patients with moderate to severely rheumatoid arthritis.
According to the FINCH studies, filgotinib met its primary endpoints and demonstrated durable effectiveness and safety results across the multiple RA patient populations, including in people with previous inadequate response to methotrexate treatment (MTX), those who were intolerant to one or more biologic treatments and also, those who were MTX treatment-naïve.Â
Safety results were reliable across the trials and advances reinforce the long-term safety and tolerability profile of filgotinib for a broad range of RA patients. https://fda.einnews.com/pr_news/505337222/gilead-submits-new-drug-application-to-u-s-food-and-drug-administration-under-priority-review-for-filgotinib-for-rheumatoid-arthritis-treatment
