On December 16, the FDA approved AbbVie’s Vraylar (cariprazine) for the adjunctive treatment of major depressive disorder (MDD) in adults. This becomes the fourth indication for Vraylar, having previously been approved by the FDA for the treatment of adults with schizophrenia, the acute treatment of manic or mixed episodes associated with bipolar I disorder, and the treatment of depressive episodes associated with bipolar I disorder (bipolar depression).

Vraylar’s approval was based on results from AbbVie’s Phase III clinical study, 3111-301-001 (NCT03738215), which was a randomized, double-blind, placebo-controlled trial to assess the safety and efficacy of the drug in adults with MDD who have had an inadequate response to antidepressants alone. Vraylar demonstrated a statistically significant change from baseline to week six of treatment in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score compared with placebo. An additional pivotal Phase III clinical study, RGH-MD-75 (NCT01469377), demonstrated a statistically significant change from baseline to week eight in the MADRS total score for patients treated with Vraylar compared with placebo. Vraylar was well tolerated in both studies, and regarding weight gain, a side effect of atypical antipsychotic drugs of particular concern to patients, ≤3% of patients had a weight increase of ≥7%.

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: US, France, Germany, Italy, Spain, UK, Japan, and Canada) 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 and offer only incremental improvements in efficacy.

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 these, including Biogen and Sage Therapeutics’s GABA A receptor allosteric modulator zuranolone and Janssen’s orexin receptor type 2 antagonist seltorexant, have novel mechanisms of action, which may grant them more of a competitive edge in the MDD market.

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