FDA advisory committees rule in favor of Rexulti for agitation associated with Alzheimer’s

Key takeaways:

• FDA advisory committees voted 9-1 in favor of a supplemental new drug application for Rexulti for treatment of agitation associated with AD.
• The Prescription Drug User Fee Act target action date is May 10.

Two FDA advisory committees voted in favor of a supplemental new drug application for Rexulti, ruling there was sufficient data to show treatment for agitation associated with Alzheimer’s dementia outweighed the risks.

According to a joint release from Otsuka and Lundbeck, the Psychopharmacologic Drugs Advisory Committee and Peripheral and Central Nervous System Drugs Advisory Committee met in a joint session to discuss the sNDA for Rexulti (brexpiprazole, Otsuka/Lundbeck) and voted 9-1 in support of the petition.

“We are thankful to the FDA and committee members for the thoughtful review and discussion of Rexulti for the treatment of agitation associated with Alzheimer’s dementia,” John Kraus, MD, PhD, Otsuka executive vice president and chief medical officer, said in the release.

The sNDA included data from two positive clinical phase 3 studies, the release stated. The first showed 2 mg per day of brexpiprazole was statistically superior to placebo in meeting the primary endpoint of mean change in Cohen-Mansfield Agitation Inventory (CMAI) total score from baseline to week 12, and the second demonstrated that 2 mg and 3 mg per day doses of brexpiprazole resulted in statistically significant improvement compared with placebo for mean change in CMAI total score from baseline to week 12.

“Agitation is one of the most complex and stressful aspects of care in patients affected by Alzheimer’s dementia,” Johan Luthman, executive vice president at Lundbeck Research & Development, said in the release. “Having an approved treatment option for AAD could provide hope to people impacted by this debilitating condition.”

Brexpiprazole would be the first FDA-approved treatment in the U.S. indicated for agitation associated with Alzheimer’s dementia, the companies stated. The FDA will review committee feedback and the sNDA in advance of the May 10 Prescription Drug User Fee Act target action date.