FDA ad­comm votes in fa­vor of ap­prov­ing Proven­tion Bio’s drug to de­lay type 1 di­a­betes

Fol­low­ing heat­ed dis­cus­sions on the small but pos­i­tive piv­otal tri­al, the FDA’s En­docrino­log­ic and Meta­bol­ic Drugs Ad­vi­so­ry Com­mit­tee on Thurs­day vot­ed 10-7 in fa­vor of the FDA ap­prov­ing Proven­tion Bio’s teplizum­ab for the de­lay of clin­i­cal type 1 di­a­betes in at-risk in­di­vid­u­als.

Com­mit­tee mem­bers seemed swayed by the clear­ly high­light­ed qual­i­ty of life im­prove­ments in the pub­lic dis­cus­sion, but with some ques­tion marks in the safe­ty da­ta and the con­fir­ma­to­ry ev­i­dence, the pan­el went back and forth on what the da­ta ac­tu­al­ly show – set­ting up a tough de­ci­sion for the FDA by Ju­ly 2. The FDA does not have to fol­low the ad­vice of its ad­comm, but it usu­al­ly does.

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