Gilead announces intent to summit new drug application for Filgotinib to U.S. Food and Drug Administration this year

Tuesday, July 2, 2019

Gilead Sciences, announced that at a recent pre-New Drug Application (NDA) meeting with the U.S. Food and Drug Administration (FDA), the company provided an update about the investigational oral, selective JAK1 inhibitor, filgotinib. The company discussed with the agency the Phase 3 FINCH studies, as well as the ongoing Phase 2 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.


About Galapagos

Galapagos discovers and develops small molecule medicines with novel modes of action, three of which show promising patient results and are currently in late-stage development in multiple diseases. Our pipeline comprises Phase 3 through to discovery programs in inflammation, fibrosis, osteoarthritis and other indications. Our ambition is to become a leading global biopharmaceutical company focused on the discovery, development and commercialization of innovative medicines. More information at www.glpg.com.


About Gilead

Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need.  The company strives to transform and simplify care for people with life-threatening illnesses around the world.  Gilead has operations in more than 35 countries worldwide, with headquarters in Foster City, California.  For more information on Gilead Sciences, please visit the company's website at www.gilead.com.

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