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.

Unlock this article instantly by becoming a free subscriber.

You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.

SIGN UP LOG IN BECOME A PREMIUM SUBSCRIBER