Gilead received a complete response letter from the FDA this week for a drug that has been pegged to become a blockbuster.
According to the company, the agency expressed concerns with how filgotinib, a JAK1 inhibitor developed to treat rheumatoid arthritis (RA) and other autoimmune conditions, could impact patients’ sperm counts. The FDA requested additional data from two ongoing studies of how filgotinib affects sperm parameters. The agency also questioned the overall benefit/risk profile of filgotinib at the 200 mg dose.
Originally touted as a potentially safer alternative to other JAK inhibitors, analysts had expected filgotinib to bring in billions in annual sales. Filgotinib’s main rival on the market for RA is going to be AbbVie’s Rinvoq, which comes with a black box warning for thrombosis.
The drug was developed by Galapagos, and was one of the main drivers behind a collaboration deal between the companies that’s worth up to $5.1 billion.
In an earlier head-to-head RA trial with AbbVie’s Humira, filgotinib showed better remission rates after 52 weeks. The drug is also being trialed as a treatment for ulcerative colitis, psoriatic arthritis and Crohn’s disease.
Now, Gilead says it will most likely not be able to refile its application for filgotinib as a treatment for RA until the middle of next year.
Read the full press release.