FDA panel backs approval of Rexulti for Alzheimer related agitation

An FDA advisory committee was almost unanimous in recommending approval of Lundbeck and Otsuka Pharmaceutical's Rexulti (brexpiprazole) to treat agitation in patients with Alzheimer's dementia (AAD), something Jefferies analysts see as "potentially unlocking a blockbuster opportunity" for the drug. A decision from the agency is expected by May 10. At a recent advisory meeting, panel members voted 9 to 1 that Otsuka and Lundbeck had provided sufficient data to allow the identification of a population in whom the benefits of treating AAD with Rexulti outweigh its risks. The vote was in line with briefing documents released by FDA staff ahead of the AdCom. The marketing application contains data from two Phase III trials in which Rexulti demonstrated a statistically significant treatment effect based on Cohen-Mansfield Agitation Inventory (CMAI) total score at week 12. Although a third late-stage study had failed to meet its primary endpoint of change in CMAI total score, FDA staff noted that the treatment effect with Rexulti "was nominally significant to placebo and numerically similar" to results in the two other trials. Jefferies analysts noted that at the meeting, "panel members viewed efficacy as clinically meaningful," and they were also "sanguine on safety given already known risks with off-label antipsychotics and the clear unmet need." The majority of committee members said they were convinced by the data for Rexulti, with panelist Robert Weisman stating "I think that the data speaks for itself, the efficacy data was positive and the safety data was very reassuring." The one vote against approval came from panel member Kim Witczak, who said "I don't think that the data demonstrates or outweighs the dangers of an antipsychotic, which this is." In the Phase III programme, eight deaths occurred among patients who received Rexulti, versus one among placebo recipients. Witczak also raised concerns over the potential advertising and marketing of the drug, noting "we really need to keep an eye on this."

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