(Reuters) – A panel of advisers to the U.S. Food and Drug Administration on Wednesday recommended against authorizing Veru Inc’s oral COVID-19 pill for treating moderate-to-severe hospitalized patients at high risk for developing acute respiratory distress syndrome.
The panel voted 8-5 against the pill’s usage.
The unfavorable vote decreases the chances of authorization for Veru, which is already lagging in the race to develop a COVID-19 treatment. If authorized, the pill would provide an additional treatment option as the disease moves from a pandemic to an endemic stage.
Veru’s oral drug, which was originally being tested as a treatment for prostate cancer, blocks the protein tubulin and prevents tumor cells from multiplying.
While data has shown the drug can also produce antiviral and anti-inflammatory responses, the FDA staff reviewers have said its mechanism of action in COVID-19 was uncertain.
(Reporting by Bhanvi Satija and Raghav Mahobe in Bengaluru; Editing by Shailesh Kuber)