U.S. FDA Confirms Review Meeting for Severe COVID-19 Patient Treatment
Florida-based Veru Inc. recently announced that the U.S. Food and Drug Administration (FDA) had informed the Company of updated meeting date for the FDA’s Pulmonary-Allergy Drugs Advisory Committee to discuss the Company’s request for Emergency Use Authorization of sabizabulin for hospitalized COVID-19 patients who are at high risk for ARDS.
As of September 19, 2022, the FDA meeting has been rescheduled to November 9, 2022.
The Company has completed a positive Phase 3 COVID-19 study evaluating sabizabulin in hospitalized moderate to severe COVID-19 patients at high risk for ARDS.
And on August 22, 2022, Australia’s Therapeutic Goods Administration determined that sabizabulin treatment in hospitalized COVID-19 patients at high risk for ARDS qualifies for an expedited, provisional registration regulatory pathway.
The FDA has previously Approved and Authorized various antivirals (oral and IV) to treat COVID-19 infections.
Additional COVID-19 treatment news is posted at PrecisionVaccinations.