After Lundbeck and Otsuka’s Rexulti cleared a key advisory committee hurdle, the FDA has given the drug the go-ahead to treat dementia-associated agitation in Alzheimer’s disease patients

With the approval, Rexulti becomes the first drug approved for this use in the United States.

The FDA granted the nod based on data from two 12-week studies in which patients showered statistically significant and clinically meaningful improvements on the Cohen-Mansfield Agitation Inventory scale, according to the FDA. The metric looks at the frequency and intensity of dementia-related agitation.

In the studies, Rexulti demonstrated a 31% improvement from baseline agitation symptoms compared with placebo.

Agitation symptoms cover a wide group of behaviors including pacing, gesturing, profanity, shouting, and physical outbursts, Otsuka said in a release.

The symptoms are the leading causes of assisted living or nursing room placement and have been known to be associated with accelerated disease progression, Tiffany Farchione, director of the FDA’s center of drug evaluation and research, psychiatry division, said in a statement.

Rexulti scored its original approval in 2015 for schizophrenia and major depressive disorder. As for the new indication, the drug last month received a 9 to 1 vote in favor of approval during an FDA advisory committee of outside experts.

In the FDA’s briefing documents ahead of the committee meeting, the agency noted that the drug's effect on mortality is “consistent” with the known risks of other antipsychotics in elderly patients with dementia.

The approval follows a flurry of activity in the Alzheimer’s disease space, including Biogen and Eisai's launch of Leqembi.

Last year, Rexulti pulled in 2.85 billion Danish kroner ($405 million) in sales for Lundbeck. In mid-2022, SVB Securities analysts noted that the agitation indication could bring in peak sales of around $500 million.

Reference: https://otsuka-us.com/news/otsuka-and-lundbeck-announce-us-food-and-drug-administration-fda-approval-supplemental-new