Gilead Sciences, Inc. has submitted an NDA to the FDA for filgotinib for the treatment of moderate-to-severe rheumatoid arthritis.

Gilead Sciences, Inc. announced that it has submitted a New Drug Application (NDA) to the FDA for filgotinib, an investigational, oral, selective JAK1 inhibitor for the treatment of adults who are living with moderate-to-severe rheumatoid arthritis (RA). A priority review voucher was submitted with the NDA, shortening the anticipated time for review.

The filing is supported by 52-week data from the global Phase III FINCH clinical program, which evaluated the efficacy and safety of filgotinib in 3,452 patients with moderate to severely active RA. In the FINCH studies, filgotinib met its primary endpoints and demonstrated durable efficacy and safety results across multiple RA patient populations, including in people with prior inadequate response to methotrexate treatment (MTX), those who were intolerant to one or more biologic treatments and those who were MTX treatment-na�ve. Safety results were consistent across the trials and further reinforce the long-term safety and tolerability profile of filgotinib for a broad range of RA patients.

Despite the availability of current therapies, people living with RA may face persistent disease symptoms and inadequate responses to currently available therapies. One in five patients do not achieve complete disease remission during their lifetimes and remain in need of treatment options.