Veru has lost a split decision at its FDA advisory committee meeting, with experts voting eight to five against the known and potential benefit-risk profile of VERU-111 in hospitalized moderate to severe COVID-19 patients who are at high risk for acute respiratory distress syndrome.
The chances of Veru securing a clear win at the meeting took a hit when the FDA published its briefing document. While the agency acknowledged that Study 902 met its primary endpoint of all-cause mortality at Day 60, it “identified a number of uncertainties with the data” from the “small trial,” including high placebo arm mortality rate, potential for unblinding events and baseline imbalances in standard of care.
Those uncertainties shaped the discussion at the advisory committee. Ultimately, the vote went against Veru by eight experts to five, but the comments revealed uncertainty on both sides of the fence, as Brigham and Women’s Hospital’s Lindsey Baden, M.D., articulated in the explanation of his vote. “I agree with all of the previous voters, both yes and no. We’re all on the edge of how do we weigh the efficacy signal and the absence of a safety signal, but the absence of safety data?” Baden said.