FDA Adcomm Votes Against Veru’s COVID-19 Therapeutic

The FDA’s Pulmonary-Allergy Drugs Advisory Committee voted against the potential Emergency Use Authorization of Veru’s COVID-19 therapeutic candidate, sabizabulin. … Dr. Daniel Gillen [Chancellor’s Professor of statistics] from the University of California at Irvine said with a limited efficacy and safety data set from the small study, there isn’t enough information to provide an answer about the risk-benefit profile. Gillen also said there is not a “full understanding of the mechanism of action” of sabizab