The US FDA Rejects Gilead's Filgotinib Due to Toxicity Issues

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The US FDA Rejects Gilead's Filgotinib Due to Toxicity Issues


  • The US FDA has issued a complete response letter for the NDA of filgotinib to treat moderately to severely active RA. FDA has requested data from two ongoing clinical trials- MANTA and MANTA-Ray assessing the effect of filgotinib (200mg) on sperm parameter
  • The authority has expressed concerns regarding the overall benefit/risk profile of the filgotinib (200mg). The company will evaluate the points raised in the CRL for discussion with the FDA and will continue to believe in the results of P-III FINCH clinical program
  • The company anticipates the study of MANTA and MANTA-RAy studies in H1’21. Filgotinib is currently under review by regulatory authorities across the globe and has received the CHMP’s positive opinion- recommending MAA for filgotinib in the EU to treat mod. to sev. RA who have responded inadequately or are intolerant to one or more disease-modifying anti-rheumatic drugs

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Ref: Gilead | Image: Gilead


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