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

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.