Gilead Sciences (GILD) - Get Gilead Sciences, Inc. Report shares eased on Wednesday after the U.S. Food and Drug Administration requested more data for its review of the drugmaker's investigational treatment for moderately to severely active rheumatoid arthritis.
The FDA wants more data on filgotinib from an ongoing clinical trial.
"The Manta and Manta-Ray studies are designed to assess whether filgotinib has an impact on sperm parameters," the Foster City, Calif., company said in a statement.
"The FDA also has expressed concerns regarding the overall benefit/risk profile of the filgotinib 200 mg dose."
"We are disappointed in this outcome and will evaluate the points raised in the [FDA complete response letter] for discussion with the FDA," said Merdad Parsey, a physician who is Gilead's chief medical officer.
"We continue to believe in the benefit/risk profile of filgotinib in rheumatoid arthritis, which has been demonstrated in the Finch Phase 3 clinical program."
The filgotinib studies are already fully recruited, with top-line results expected in the first half of 2021, Gilead said.
'Filgotinib is currently under review by regulatory authorities around the world," the company said.
The drug "recently received a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use, recommending marketing authorization for filgotinib in the EU for the treatment of adults with moderate to severe RA who have responded inadequately or are intolerant of one or more disease-modifying anti-rheumatic drugs."
Fierce Biotech estimated that Gilead might not be able to refile its application until mid-2021. The news service estimated an early 2022 FDA clearance based on that timeline.
Analysts at Jefferies in a note last month cited by Fierce Biotech said that the drug could eventually generate $2 billion to $3 billion annually.
“Filgotinib could be 'best in class' although fourth to market - and we acknowledge rebating will also be key here in the competitive market," the firm said in its note, according to Fierce Biotech.
Gilead shares at last check were down 3.6% to $66.60.