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# Gilead Filgotinib Complete Response Letter
- URL: https://www.fdaweb.com/gilead-filgotinib-complete-response-letter/
- Published: 2020-08-19T12:00:00.000Z
- Updated: 2026-09-14T16:25:31.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5147466

FDA has issued a complete response letter to Gilead Sciences for its NDA for filgotinib to treat moderately to severely active rheumatoid arthritis. The company [says](https://www.gilead.com/news-and-press/press-room/press-releases/2020/8/gilead-receives-complete-response-letter-for-filgotinib-for-the-treatment-of-moderately-to-severely-active-rheumatoid-arthritis?ref=fdaweb.com) the agency requested data from the MANTA and MANTA RAy studies before completing the NDA review. It says the studies are intended to assess whether filgotinib has an impact on sperm parameters. And the agency expressed concern about the overall benefit/risk profile of the filgotinib 200 mg dose, Gilead says.

Company officials said they were disappointed to receive the letter and will evaluate the points raised in it for discussion with FDA.