News
Gilead Sciences and Galapagos NV receive complete response letter from FDA for filgotinib, an investigational treatment for moderately to severely active rheumatoid arthritis.
Gilead Sciences, Inc. has announced that the FDA has issued a complete response letter (CRL) for the New Drug Application (NDA) for filgotinib, an investigational treatment for moderately to severely active rheumatoid arthritis (RA).
The FDA has requested data from the MANTA and MANTA-RAy studies before completing its review of the NDA. The MANTA and MANTA-RAy studies are designed to assess whether filgotinib has an impact on sperm parameters. The FDA also has expressed concerns regarding the overall benefit/risk profile of the filgotinib 200 mg dose.
Condition: Rheumatoid Arthritis
Type: drug
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