The FDA’s Pulmonary-Allergy Drugs Advisory Committee Meeting will convene on 9 November 2022 to discuss the request for Emergency Use Authorization (EUA) for sabizabulin oral capsule, a tubulin polymerization inhibitor, submitted by Veru Inc., for the treatment of SARS-CoV-2 infection in moderate to severe COVID-19 infections at high risk of acute respiratory distress syndrome.
Sabizabulin is an oral, novel microtubule disruptor that has dual antiviral and anti-inflammatory activities in preclinical models.
A focus of the discussion will include the treatment effect size in the context of the high placebo mortality rate, the limited size of the safety database, and identifying the proposed population.
Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. FDA is establishing a docket for public comment on this meeting. The docket number is FDA-2022-N-2107.
Please visit the FDA’s Meeting of the Pulmonary-Allergy Drugs Advisory Committee Meeting Announcement for more information.