FDA ad­comm votes in fa­vor of first drug for ag­i­ta­tion as­so­ci­at­ed with Alzheimer's de­men­tia

A joint meet­ing of two FDA ad­comms on Fri­day vot­ed 9-1 in fa­vor of Ot­su­ka and Lund­beck’s drug Rex­ul­ti (br­ex­pipra­zole) for ag­i­ta­tion as­so­ci­at­ed with Alzheimer’s de­men­tia (AAD).

First ap­proved in 2015 for schiz­o­phre­nia and as an an ad­junc­tive ther­a­py to an­ti­de­pres­sants in adults with ma­jor de­pres­sive dis­or­der, Ot­su­ka said at the meet­ing that all three place­bo-con­trolled Phase III tri­als con­tributed to show­ing the ef­fi­ca­cy in the AAD in­di­ca­tion, and the safe­ty pro­file of the an­tipsy­chot­ic was on par with oth­ers.

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