Gilead Sciences has submitted a New Drug Application (NDA) to the Food and Drug Administration (FDA) for priority review of filgotinib for the treatment of moderate to severe rheumatoid arthritis (RA) in adult patients.
The application is supported by data from the phase 3 FINCH clinical program that evaluated the efficacy and safety of filgotinib in patients with moderate to severe RA (N=3452). Filgotinib was assessed across multiple RA patient populations, which included patients with prior inadequate response to methotrexate (MTX), those who were intolerant to ≥1 biologic disease-modifying antirheumatic drug (DMARD), and those who were MTX treatment-naive.
Week 52 data from the FINCH 1 and FINCH 3 trials showed filgotinib met its primary end points, achieving statistically significant American College of Rheumatology 20% responses (ACR20) at weeks 12 and 24, compared with placebo, in patients that had an inadequate response to MTX or who were naive to MTX therapy. In addition, a consistent safety profile was observed across all trials.
“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.”
Filgotinib, an oral selective JAK1 inhibitor, is currently being investigated for additional inflammatory indications, including the EQUATOR phase 2 program in psoriatic arthritis, the TORTUGA phase 2 study in ankylosing spondylitis, the DIVERSITY phase 3 trial in Crohn disease (also small bowel and fistulizing Crohn disease phase 2 studies) and the phase 3 SELECTION trial in ulcerative colitis.
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