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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 Rejects Gilead's Filgotinib Due to Toxicity Issues

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  • 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


Tuba

Tuba was Senior Editor at PharmaShots. She was curious, creative, and passionate about recent updates and innovations in the life sciences industry. She covered Biopharma, MedTech, and Digital health segments. Tuba also had an experience in digital and social media marketing and ran the campaigns independently. She can be contacted at connect@pharmashots.com.

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