Posted by Michael Wonder on 21 Dec 2019
Gilead submits filgotinib new drug application to U.S. FDA under priority review for rheumatoid arthritis treatment
19 December 2019 - Gilead Sciences announced today that it has submitted a new drug application to the U.S. FDA for filgotinib, an investigational, oral, selective JAK1 inhibitor for the treatment of adults who are living with moderate-to-severe rheumatoid arthritis.
A priority review voucher was submitted with the application, shortening the anticipated time for review.
The filing is supported by 52-week data from the global Phase 3 FINCH clinical program, which evaluated the efficacy and safety of filgotinib in 3,452 patients with moderate to severely active rheumatoid arthritis.
