Panel Votes Down Veru Covid Therapy

FDA’s Pulmonary-Allergy Drugs Advisory Committee 11/9 voted 8 to 5 to recommend against an emergency use authorization for Veru’s investigational prostate cancer drug VERU-111 (sabizabulin) and its use as a treatment for hospitalized adults with moderate to severe Covid-19 who are at high risk for acute respiratory distress syndrome.

Panel members agreed with FDA concerns raised in a briefing document released before the meeting. The agency reviewers said that while the single study submitted by Veru met its prespecified primary endpoint of all-cause mortality at Day 60, they noted it was quite small in size (204 patients) compared to other therapeutic programs for patients hospitalized with Covid-19. They said uncertainties with the trial data include high placebo group mortality rate, baseline imbalances in standard-of-care therapies, and differences in hospitalization duration before trial enrollment, among other issues.