FDA Rejects Gilead’s Rheumatoid Arthritis New Drug Application

Gilead submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for filgotnib, a treatment for rheumatoid arthritis, which the FDA rejected due to safety concerns, particular in the 200mg dose. “We are disappointed in this outcome and will evaluate the points raised in the CRL for discussion with the FDA,” said Gilead’s chief medical officer Merdad Parsey. Gilead is not expected to refile for filgotnib before the end of the year, creating major setbacks for the company, falling behind their competition in the JAK inhibitor market.

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