AbbVie snags depression indication for antipsychotic blockbuster

Dec. 20, 2022

The FDA has granted AbbVie a fourth indication for its blockbuster antipsychotic therapy Vraylar, approving it as an adjunctive therapy to antidepressants for the treatment of major depressive disorder in adults (MDD).

Vraylar is an oral, once-daily atypical antipsychotic that had been already approved for the treatment of schizophrenia, acute manic or mixed episodes associated with bipolar 1, and bipolar depression. First approved in 2015,  the drug works by targeting agonist activity in dopamine receptors in the brain. 

AbbVie's recent indication for MDD was supported by studies showing the drug’s tolerability and effectiveness in improving depression symptoms. In its phase 3 study, Vraylar showed a clinically and statistically significant change from baseline to week six in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score for patients treated with it at 1.5 mg/day and adjunctive therapy compared with placebo and adjunctive therapy. 

The drug has already reached blockbuster status with its current indications, and the Humira king is assessing its effectiveness for other psychiatric disorders as well.