The FDA rejected Gilead's application to sell filgotinib as a rheumatoid arthritis treatment on the evening of Aug. 18, halting the drugmaker's forward-thinking plans for the therapy it had purported to be a future cash cow.
The agency said it would reconsider its decision only after Gilead can offer more data about filgotinib's effect on users' sperm counts. The drugmaker is conducting two studies to produce that data, but results will not be ready until sometime in 2021.
The FDA's rejection creates obstacles for Gilead's long-term vision for the drug. The drugmaker hoped to grow filgotinib into a major treatment, with plans to seek FDA approval for the drug to treat psoriatic arthritis, inflammatory bowel disease, ankylosing spondylitis and eye inflammation.
"We are disappointed in this outcome and will evaluate the points raised in the [complete response letter] for discussion with the FDA," Merdad Parsey, MD, PhD, Gilead's CMO, said in a statement. "We continue to believe in the benefit/risk profile of filgotinib in RA, which has been demonstrated in the FINCH Phase 3 clinical program."