Axsome wins FDA priority review for Auvelity in Alzheimer’s disease agitation

The U.S. Food and Drug Administration has accepted Axsome Therapeutics’ (NASDAQ:AXSM) supplemental New Drug Application for AXS-05 to treat Alzheimer’s disease agitation and granted it Priority Review designation, the company announced.

The FDA has set a target action date of April 30, 2026, for the application. Priority Review designation shortens the FDA’s review timeline to six months from the standard ten months.

AXS-05, a combination of dextromethorphan HBr and bupropion HCl, previously received Breakthrough Therapy designation for Alzheimer’s disease agitation in June 2020.

"Up to 76% of people with Alzheimer’s disease experience agitation, representing a significant unmet medical need for patients and their caregivers, and currently there is a dearth of approved treatments," said Herriot Tabuteau, Chief Executive Officer of Axsome, according to the press release. This market opportunity has helped drive Axsome’s remarkable 65.83% revenue growth over the last twelve months, with the company maintaining an exceptional 91.86% gross profit margin despite not yet achieving overall profitability.

The supplemental application is supported by data from four randomized, double-blind, controlled Phase 3 clinical trials and a long-term safety trial.

https://au.investing.com/news/company-news/fda-grants-priority-review-for-axsomes-alzheimers-agitation-drug-93CH-4187582