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FDA Is Still Lenient On COVID-19 EUAs, Veru’s Sabizabulin Advisory Panel Preview Docs Indicate

 
• By Sarah Karlin-Smith

Agency poised to authorize Veru’s NME for COVID acute respiratory distress despite potential efficacy concerns and an unusually small safety database even by EUA standards. FDA assessment highlights continued burden of COVID despite political rhetoric downplaying current impact.

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Agency still sees reasons to be flexible and grant EUAs for COVID-19 treatments, Veru’s adcomm preview documents indicate • Source: Shutterstock

COVID-19 therapeutics still command a lot of US Food and Drug Administration flexibility when it comes to emergency use authorizations, agency advisory committee preview documents released ahead of Veru Inc.’s 9 November panel review for its acute respiratory distress syndrome treatment indicate.

Veru is seeking an authorization for sabizabulin (VERU-111) for the treatment of hospitalized adults with moderate to severe COVID-19 who are at high risk for acute respiratory distress syndrome (ARDS)

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