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Gilead’s RA Hopeful Filgotinib Hit By Complete Response Letter

FDA Concerned About High Dose And Testicular Side Effects

 
• By Andrew McConaghie

Complete Response Letter is a major setback for Gilead and its partner Galapagos.  

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• Source: Shutterstock

Gilead Sciences, Inc. has received a complete response letter (CRL) from the US Food and Drug Administration for filgotinib, its blockbuster prospect for rheumatoid arthritis, because of safety concerns.

The FDA has requested data from two pending clinical studies, MANTA and MANTA-RAy before completing its review of the drug,...

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