According to the National Institutes of Health, an estimated 7% of U.S. adults, or approximately 19 million, experience MDD each year, as reported by Axsome Therapeutics (AXSM).
In addition, “according to the World Health Organization (WHO), depression is the leading cause of disability worldwide, and is a major contributor to the overall global burden of disease. Nearly two-thirds of diagnosed and treated patients do not experience adequate treatment response with currently available first-line therapy, highlighting the need for additional therapies with new mechanisms of action,” they added.
However, Axsome Therapeutics may be able to help.
The company just announced the U.S. FDA accepted a new drug application (NDA) for AXS-05 for the treatment of MDD, and has also granted priority review.
“We are pleased with the FDA’s acceptance and Priority Review designation of our NDA for AXS-05 in major depressive disorder, and we look forward to continuing to work closely with the FDA throughout the review process,” said Herriot Tabuteau, MD, Chief Executive Officer of Axsome, as quoted in a company press release. “If approved, AXS-05 would be an important new treatment option for the many Americans living with depression.”
In addition, the US FDA previously granted Breakthrough Therapy Designation for AXS-05 for the treatment of MDD in March 2019. The FDA also granted Breakthrough Therapy Designation for AXS-05, for a second indication, Alzheimer’s disease agitation in June 2020.
At the moment, shares of AXSM are up 13%, or $7 on the news.
Axsome Provides Business Update
“The focused execution of the Axsome team made 2020 a year of significant accomplishments. We had successful pre-NDA meetings with the FDA for AXS-05 in major depressive disorder and for AXS-07 in migraine, reported positive results from the pivotal ADVANCE-1 trial of AXS-05 in Alzheimer’s disease agitation, initiated the second pivotal trial of AXS-05 in this indication, received two new FDA Breakthrough Therapy designations, and built out our commercialization infrastructure,” said added Tabuteau.
“So far this year, we have submitted to the FDA the NDA for AXS-05 in major depressive disorder, and are nearing submission of the NDA for AXS-07 in the acute treatment of migraine, which is expected early in the second quarter. Our focus for the remainder of the year will be on the regulatory activities surrounding these NDAs, launch readiness to ensure a successful transition to commercialization, assuming product approvals, and continued advancement of the rest of our differentiated late-stage CNS pipeline.”
At the time of this writing, Ian Cooper did not hold a position in AXSM.