Gilead submits new drug application to U.S. Food and Drug Administration under priority review for filgotinib for rheumatoid arthritis treatment
Foster City, Calif., and Mechelen, Belgium; 19 December 2019, 22.30 CET – Galapagos NV (Euronext & NASDAQ: GLPG) today announced that its collaboration partner, Gilead Sciences, Inc. (NASDAQ: GILD) 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). A priority review voucher was submitted with the NDA, shortening the anticipated time for review.
The NDA 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 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-naïve. 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.
As part of the collaboration terms, upon NDA submission, Galapagos receives a $20 million milestone payment from Gilead.
This NDA is the third regulatory agency submission for filgotinib in the past 5 months following submissions to the European Medicines Agency and Japanese Ministry of Health, Labor and Welfare earlier this year.
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.
“The new drug application submission for filgotinib represents an important step forward in bringing a potential new treatment option to people living with RA,” said Merdad Parsey, MD, PhD, Chief Medical Officer, Gilead Sciences. “In clinical trials, filgotinib has demonstrated an efficacy and tolerability profile that may offer meaningful improvements in RA treatment response for patients with this chronic, debilitating disease.”