Following today’s news (26 April) that the Food and Drug Administration (FDA) has accepted Axsome Therapeutics’ new drug application (NDA) for its novel antidepressant therapy AXS-05, and granted it priority review;

Philippa Salter, Neurology Analyst at GlobalData, a leading data and analytics company, offers her view:

“GlobalData forecasts that AXS-05 will have the potential to become a blockbuster drug by 2026, with global sales of approximately $1.3bn by 2029. The expectation that this novel, multimodal antidepressant will have a significant impact on the MDD market is further backed by the FDAs decision to grant AXS-05 priority review.

“In clinical trials, AXS-05 has demonstrated rapid and sustained anti-depressive effects, which will enable it to meet some of the key unmet needs that exist in the major depressive disorder (MDD) market for more effective therapies, as well as for therapies with a rapid onset of action. Hence, GlobalData expects strong uptake of AXS-05 when it reaches the market.

“Despite the promise AXS-05 holds, it is still unlikely it to become a first-line therapy for MDD. The current first-line therapies, such as the selective serotonin reuptake inhibitors (SSRIs) and the serotonin-norepinephrine reuptake inhibitor (SNRIs), are very well entrenched in the market and have the advantage of being available as cheap generics, making it challenging for new, more expensive therapies to compete.”