An FDA advisory panel voted 5-to-8 to recommend rejecting a new drug for patients hospitalized with Covid-19, ruling that a glimmer of potential life-saving benefit couldn’t make up for a long list of questions around the company’s main trial.
The debate centered around sabizabulin, a molecule originally put in development for cancer but repurposed during the pandemic. In April, the drug made headlines after its developer, Veru Inc, announced that it dramatically slashed deaths in a clinical trial of severe Covid patients: Nearly half of patients on placebo died, compared to 20% on the drug.
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