Gilead reports discussions with FDA relating to filing of filgotinib for Rheumatoid Arthritis
Gilead Sciences, Inc. announced that at a recent pre-New Drug Application (NDA) meeting with the FDA, the company provided an update about the investigational, oral, selective JAK1 inhibitor filgotinib. The company discussed with the agency the Phase III FINCH studies, as well as the ongoing Phase II MANTA safety study assessing semen parameters with filgotinib treatment in men with moderately to severely active ulcerative colitis or Crohn’s disease.
As a result of this discussion, a path forward has been established to submit the NDA for filgotinib as a treatment for rheumatoid arthritis in 2019. Filgotinib is an investigational agent and not approved anywhere globally. Its efficacy and safety have not been established.
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