Veru AdComm Highlights Differing EUA Philosophies Based On Lingering COVID-19 Deaths

In a close but negative panel vote on the company’s acute respiratory distress syndrome treatment VERU-111 (sabizabulin), majority of US FDA advisory committee says more study should come ahead of an emergency use authorization, not as an authorization condition.

diverging paths with arrows
FDA advisors split on whether further study of VERU-111 should come before of after an EUA • Source: Shutterstock

Veru Inc. may need to conduct another study of its COVID-19 therapeutic ahead of an emergency use authorization following a negative 9 November US Food and Drug Administration advisory panel.

The Pulmonary-Allergy Drugs Advisory Committee voted 8-5 that the known and potential benefits of VERU-111 (sabizabulin) do not outweigh the...

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