FDA ten­ta­tive­ly hints at EUA, with a tri­al re­quire­ment, for Veru's new Covid drug ahead of ad­comm

While ac­knowl­edg­ing that Veru’s po­ten­tial drug for Covid-19 hos­pi­tal­iza­tions hit the mark on mor­tal­i­ty in a small tri­al, and may have enough for an EUA with a con­fir­ma­to­ry tri­al add-on, the FDA al­so point­ed to un­cer­tain­ties in the da­ta ahead of an ad­comm meet­ing Wednes­day.

The FDA’s Pul­monary-Al­ler­gy Drugs Ad­vi­so­ry Com­mit­tee will dis­cuss the re­pur­posed drug, known as sabiz­ab­u­lin, which was orig­i­nal­ly tar­get­ed at cas­tra­tion-re­sis­tant prostate can­cer and now may be au­tho­rized for hos­pi­tal­ized adults with mod­er­ate to se­vere Covid-19 who are at high risk for acute res­pi­ra­to­ry dis­tress syn­drome.

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