Mitchell Steiner, Veru CEO

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

The FDA’s Pul­monary-Al­ler­gy Drugs Ad­vi­so­ry Com­mit­tee on Wednes­day vot­ed 8-5 against Veru’s re­pur­posed can­cer drug, sabiz­ab­u­lin, as a treat­ment for cer­tain hos­pi­tal­ized adults with Covid-19, ar­gu­ing the ben­e­fits do not out­weigh the risks.

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.

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