Update on FDA Advisory Committee Meeting regarding Emergency Use Authorization of sabizabulin to treat hospitalized COVID-19 patients at high risk for acute respiratory distress syndrome
Veru Inc. announces the results of the meeting of the FDA's Pulmonary-Allergy Drugs Advisory Committee (PADAC), which reviewed sabizabulin for Emergency Use Authorization (EUA) in hospitalized moderate to severe COVID-19 patients who are at high risk for acute respiratory distress syndrome (ARDS)
The advisory committee voted 8-5 that the known and potential benefits of sabizabulin when used for the treatment of adult patients hospitalized with COVID-19 at high risk of ARDS do not outweigh the known and potential risks of sabizabulin. However, there was additional discussion around the clinical trial design aspects of an additional clinical trial as a potential post authorization requirement. FDA will consider the input of the advisory committee as part of their review of the EUA and render a decision on the Emergency Use Authorization.
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