FDA signs off on Ot­su­ka, Lund­beck­'s an­tipsy­chot­ic for Alzheimer's ag­i­ta­tion

The FDA has ap­proved Ot­su­ka and Lund­beck’s an­tip­sy­chot­ic Rex­ul­ti for ag­i­ta­tion as­so­ci­at­ed with de­men­tia due to Alzheimer’s dis­ease, bring­ing to mar­ket the first ther­a­py de­signed to treat a symp­tom that is thought to af­fect half of the pa­tients with the dis­ease.

The ap­proval, which was an­nounced Thurs­day, is based on two Phase III tri­als that showed im­prove­ment in base­line scores on an ag­i­ta­tion-mea­sur­ing sur­vey, called the Co­hen-Mans­field Ag­i­ta­tion In­ven­to­ry (CMAI), af­ter 12 weeks. The com­pa­nies had pre­vi­ous­ly re­port­ed re­sults of two Phase III tri­als back in 2017, af­ter one tri­al met — and the oth­er missed — the pri­ma­ry end­point of change in base­line of CMAI score.

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