FDA adcomm votes narrowly against Veru’s Covid drug, citing uncertainties amid mortality benefit in small trial

The vote against Veru’s drug followed a close dissection of the pivotal randomized, double-blind, placebo-controlled clinical trial for sabizabulin in 204 patients hospitalized with Covid-19, which was stopped early due to efficacy and showed a strong mortality benefit. Adcomm panelist [and Chancellor’s Professor] Daniel Gillen of the University of California, Irvine voted against sabizabulin’s benefit-risk profile as he said there is limited safety and efficacy data, without a full understanding of the mechanism of action. Panelist Janet Lee of the University of Pittsburgh School of Medicine voted against and said she would like to see a new trial design.