FDA ad­comm votes 12-1 against Le­vo Ther­a­peu­tic­s' nasal spray for a dis­or­der that caus­es in­sa­tiable hunger

The FDA’s Psy­chophar­ma­co­log­ic Drugs Ad­vi­so­ry Com­mit­tee on Thurs­day vot­ed 12 to 1 against ap­prov­ing Le­vo Ther­a­peu­tics’ nasal spray for Prad­er-Willi syn­drome, a dif­fi­cult-to-treat dis­ease that leaves pa­tients with con­stant, in­sa­tiable hunger.

Those who vot­ed no raised con­cerns about a lack of sub­stan­tial ev­i­dence, as a 9.6 mg dose of the drug failed the pri­ma­ry end­points in a Phase III tri­al. Look­ing for a sil­ver lin­ing, Le­vo turned to a 3.2 mg dose which met the tri­al’s sec­ondary end­points. But ad­comm mem­bers won­dered whether Le­vo could repli­cate those pos­i­tive re­sults.

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