FDA staff flags several uncertainties with Veru’s COVID-19 drug
Nov 7 (Reuters) – U.S. Food and Drug Administration staff said on Monday Veru Inc’s (VERU.O) experimental drug for COVID-19 met the main goal of reducing the death rate in a late-stage trial, but flagged a number of uncertainties with the data.
Staff reviewers said the data did not help in clearly identifying a relevant patient population and remained unclear about the mortality rate in the placebo group.
Veru has applied for emergency use authorization for its drug, sabizabulin, as a treatment for hospitalized moderate-to-severe COVID patients at high risk of developing an acute respiratory distress syndrome.
The application is based on data from a study involving 210 patients that showed sabizabulin led to a 55.2% reduction in death rates versus placebo.
A panel of FDA’s outside experts is scheduled to discuss approval of the drug later this week.
Shares of Veru rose 16.6% in early trading.
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