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.
But the trial was relatively small, with just over 200 patients overall. Experts noted that, among other issues, the death rate in the group on placebo seemed unusually high — suggesting the effect could be due to chance, or issues with the trial itself — and that many patients on both arms didn’t receive the medicines now commonly used in U.S. hospitals, making it unclear how the drug would fit into treatment protocols.
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