Ahead of ad­comm, FDA backs Rex­ul­ti for first ap­proval for ag­i­ta­tion as­so­ci­at­ed with Alzheimer’s de­men­tia

A la­bel ex­pan­sion is like­ly in the cards for Ot­su­ka and Lund­beck’s drug Rex­ul­ti (br­ex­pipra­zole) as the FDA said ahead of a Fri­day ad­comm that the duo pro­vid­ed enough ef­fi­ca­cy ev­i­dence for Rex­ul­ti to be ap­proved as a treat­ment for ag­i­ta­tion as­so­ci­at­ed with Alzheimer’s de­men­tia (AAD).

If ap­proved for AAD, Rex­ul­ti would be the first an­tipsy­chot­ic ap­proved this in­di­ca­tion, al­though the FDA notes in its brief­ing doc­u­ments re­leased to­day that an­tipsy­chotics are com­mon­ly pre­scribed off-la­bel for AAD. The FDA’s Psy­chophar­ma­co­log­ic Drugs Ad­vi­so­ry Com­mit­tee and its Pe­riph­er­al and Cen­tral Ner­vous Sys­tem Drugs Ad­vi­so­ry Com­mit­tee will meet on Fri­day to dis­cuss the la­bel ex­pan­sion.

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