top of page

FDA says no to Gilead’s most anticipated product filgotinib

Updated: Aug 21, 2020

In a significant disappointment for Gilead, the US Food and Drug Administration has issued a complete response letter (CRL) to rheumatoid arthritis drug candidate, filgotinib. The US FDA issues CRLs to drugs for which the review cycle has been complete, and the drug cannot be approved with the current application for the specific indication.

As per the company’s statement, FDA has asked for the MANTA and MANTA-RAy studies, which were designed to assess the impact of filgotinib on the sperm parameters. Severe concerns were raised on the benefit/risk ratio of the product.

Filgotinib has received the CHMP positive in July in Europe. The product received a positive recommendation for treating adult patients with moderate to severe rheumatoid arthritis.

Filgotinib has been developed in a collaboration between Gilead and Galapagos. Gilead has the right for commercialization in the United States. The company has conducted FINCH Phase 3 trial to evaluate the efficacy of the product in rheumatoid arthritis. The drug is in Phase 3 trials for ulcerative colitis, Crohn’s disease, psoriatic arthritis. Currently, the product is in Phase 2 trials for uveitis, small bowel, and fistulizing Crohn’s disease.


For pipeline, market overview, SLRs, and market access reports (syndicate and customised) please write to

For all syndicate reports: Click here


Recent Posts

See All

Australia Healthcare News | Media | Updates

New medications, Jemperli and Korsuva will be available for endometrial cancer and chronic kidney disease For women facing advanced or recurring endometrial cancer, a medication called Jemperli (dosta


bottom of page