A panel of outside advisers to the U.S. health regulator on Wednesday voted against authorizing Veru Inc.’s drug for treating high-risk patients hospitalized with COVID-19, citing multiple concerns over efficacy and safety data being based on a small trial.
The panel voted 8–5 against the oral drug sabizabulin’s usage and hinted that Veru gather additional data, preferably from a larger sample, regarding the drug’s ability to treat COVID-19.
“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….