FDA rejects filgotinib for moderate to severe active rheumatoid arthritis
The U.S. Food and Drug Administration has issued a complete response letter for the New Drug Application for filgotinib for moderately to severely active rheumatoid arthritis (RA), according to a press release from Gilead Sciences, Inc.
According to the press release, the FDA requested data from the MANTA and MANTA-RAy studies which assessed the impact filgotinib has on sperm parameters. In addition, the FDA also expressed concerns on the overall benefit/risk profile of the filgotinib 200 mg dose.
“We are disappointed in this outcome and will evaluate the points raised in the complete response letter for discussion with the FDA. We continue to believe in the benefit/risk profile of filgotinib in RA, which has been demonstrated in the FINCH Phase 3 clinical program,” said Merdad Parsey, MD, PhD, Chief Medical Officer, Gilead Sciences in a statement.