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.
Signage is seen outside of the Food and Drug Administration headquarters in White Oak, Maryland, U.S., August 29, 2020. REUTERS/Andrew Kelly/File Photo
drug for treating high-risk patients hospitalized with COVID-19, citing multiple concerns over efficacy and safety data being based on a small trial. "Even though 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.
While data shows sabizabulin can also produce antiviral and anti-inflammatory responses, the U.S. Food and Drug Administration staff reviewers have said its effects against COVID-19 are uncertain.
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