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Gilead 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 adults who are living with moderate-to-severe rheumatoid arthritis (RA).
The NDA is the first step in trying to gain FDA approval of a new drug. The company says that a priority review voucher was submitted with the NDA, hoping this will shorten 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 RA.
In the FINCH studies, filgotinib met its primary endpoints, demonstrating efficacy and safety results in multiple RA patient populations, including patients with:
- Prior inadequate response to methotrexate treatment (MTX)
- Those who intolerant to one or more biologic treatments; and
- MTX treatment-naïve patients.
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.
Earlier this year, filgotinib was submitted for regulatory approval from the European Medicines Agency and Japanese Ministry of Health, Labor and Welfare.
Filgotinib is an investigational agent and is not approved by any regulatory authority. Its efficacy and safety have not been established.