Axsome receives clearance to NDA filing for AXS-05 and Priority Review designation

Announcement

Axsome Therapeutics, Inc., a leading biopharmaceutical company revolutionising the treatment space of central nervous system (CNS) disorders, received acceptance from the U.S. Food and Drug Administration (FDA) for its filing of the supplemental New Drug Application (NDA) for AXS-05 (bupropion HCI and dextromethorphan HBr). The NDA is for the treatment of Alzheimer’s disease agitation and has further earned the Priority Review Designation from the FDA. The latest the FDA has fixed a Prescription Drug User Fee Act (PDUFA), focusing on an action date of 30th April 2026.

Priority Review terms

The priority review is awarded by the FDA to applications for medicines that, if qualified and approved, would serve noteworthy improvements in the safety or impact of the diagnosis, prevention or treatment of severe conditions listed under priority applications. A Priority Review designation generally means that the FDA’s motive is to respond to an application in 6 months rather than waiting for 10 long months.

MD, Chief Executive Officer of Axsome, Herriot Tabuteau, said, “We are grateful to the FDA for accepting and rewarding priority review to our supplemental NDA for AXS-05 for the cure of Alzheimer’s disease agitation. Around 76% of individuals with experience of Alzheimer’s disease agitation show a noteworthy unmet medical need ratio for caregivers and patients. So far, there’s a shortage of approved treatments. We are looking forward to continuing to build a strong and promising work relationship with the FDA regarding the pending review.”

AXS-05

Previously, the FDA awarded a Breakthrough Therapy designation to AXS-05 in June 2020 for Alzheimer’s disease agitation. This designation was granted to effectively with more power review timelines and fuel development for a convincing investigational medicine. Whereas, the clinical proven evidence shows the possibility of illustrating exponential improvement in one or numerous clinically meaningful endpoints over the existing therapies for an extreme or heart-wrenching condition.

The supplemental NDA is the pinnacle of a robust clinical development program of AXS-05 in Alzheimer’s disease agitation involving double blind, balanced and shuffled Phase 3 clinical and long-standing safety trial.

Alzheimer's is the general form of dementia that has affected around 7 million people in the United States to date. The agitation is observed 76% of patients with AD and is further specified by verbal, physical and emotional distress aggresiveness, disinhibition and disruptive irritability. This prioritised review will bring a new solution to the AD patients in the near future.