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.
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