Following the news that AbbVie’s Vraylar (cariprazine) gained approval from the FDA for the adjunctive treatment of major depressive disorder (MDD) in adults;

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

“In the MDD market, there is a need for therapies that can treat patients who are inadequately responding to currently available antidepressants. The approval of Vraylar will provide a new treatment option for these patients. GlobalData anticipates good uptake of the drug since key opinion leaders (KOLs) previously interviewed by GlobalData confirmed that some physicians were already using Vraylar off-label as an adjunctive therapy for the treatment of MDD. GlobalData forecasts Vraylar will generate global (8MM*) sales of approximately $741.2 million by 2029.

“However, a barrier to the uptake of Vraylar could be its high cost of therapy when compared to other low-cost atypical antipsychotic generics, such as aripiprazole and quetiapine, which are already widely used as adjunctive therapies for MDD. This concern was highlighted by KOLs, who noted that Vraylar could struggle in the MDD market as a ‘me-too’ atypical antipsychotic drug that would be more expensive than what is already available on the market.

“Further competition for Vraylar will also come from other late-stage pipeline products being developed as adjunctive therapies for MDD that are expected to enter the market over the next decade. Several of which, including Biogen and Sage Therapeutics’ zuranolone and Janssen’s seltorexant, have novel mechanisms of action, which may grant them more of a competitive edge in the MDD market.”

* 8MM = US, France, Germany, Italy, Spain, UK, Japan and Canada