FDA rejects Covid-19 drug over uncertainties around small trial
Following the advice of a panel of outside experts, the FDA has turned down a potential Covid-19 drug that only had data from a small trial.
Miami, FL-based Veru had repurposed a microtubule disruptor called sabizabulin, which it had been testing in cancer, to treat hospitalized adult patients with moderate to severe Covid-19 who are at high risk for ARDS, or acute respiratory distress syndrome.
CEO Mitchell Steiner suggested that the FDA rejected the drug “because of the possibility of unknown influences, or uncertainties that may have affected the study.” The company noted that the agency offered comments for a proposed confirmatory Phase III.