FDA re­jects Covid-19 drug over un­cer­tain­ties around small tri­al

Fol­low­ing the ad­vice of a pan­el of out­side ex­perts, the FDA has turned down a po­ten­tial Covid-19 drug that on­ly had da­ta from a small tri­al.

Mi­a­mi, FL-based Veru had re­pur­posed a mi­cro­tubule dis­rup­tor called sabiz­ab­u­lin, which it had been test­ing in can­cer, to treat hos­pi­tal­ized adult pa­tients with mod­er­ate to se­vere Covid-19 who are at high risk for ARDS, or acute res­pi­ra­to­ry dis­tress syn­drome.

CEO Mitchell Stein­er sug­gest­ed that the FDA re­ject­ed the drug “be­cause of the pos­si­bil­i­ty of un­known in­flu­ences, or un­cer­tain­ties that may have af­fect­ed the study.” The com­pa­ny not­ed that the agency of­fered com­ments for a pro­posed con­fir­ma­to­ry Phase III.

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