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Gilead Sciences Plans To Submit NDA For Filgotinib To FDA In 2019

Gilead Sciences, Inc. (GILD), a research-based biopharmaceutical company, announced its intent to submit new drug application or NDA for Filgotinib as a treatment for rheumatoid arthritis to U.S. Food and Drug Administration in this year.

Filgotinib is an investigational agent and not approved anywhere. Its efficacy and safety is yet to be established.

At a recent pre-NDA meeting with the FDA, the company provided an update about the investigational, oral, selective JAK1 inhibitor filgotinib. The company said it discussed 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.

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