Nov 9 (Reuters) – A panel of advisers to the U.S. Food and Drug Administration on Wednesday voted against authorizing Veru Inc’s (VERU.O) 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 oral drug sabizabulin’s usage.
“Even though (the data) is impressive for a new molecular entity – it has no direct evidence to support the antiviral activity,” said panel member Susanne May, who voted against authorization of the drug.
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 sabizabulin, 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.
Veru’s application for authorization in the United States was based on data from a late-stage study of 210 patients that showed the drug helped in a 55.2% reduction in death rates versus placebo.
Prior to the panel’s meeting, the agency’s reviewers had flagged several issues with the data from Veru’s COVID-19 drug, citing that it does not help clearly identify a relevant patient population and the high rate of deaths in a placebo group in the trial raises questions about the results.
The FDA is not obligated to follow the recommendations of the panel, but usually does.
Reporting by Bhanvi Satija and Raghav Mahobe in Bengaluru; Editing by Shailesh Kuber
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