AbbVie's Antipsychotic Drug Scores FDA Approval As Adjunct Therapy For Depression Patients - AbbVie (NYSE:ABBV)

The FDA approved AbbVie Inc's ABBV Vraylar (cariprazine) as an adjunctive therapy to antidepressants for major depressive disorder (MDD) in adults.
Supported by clinical data demonstrating efficacy and well-established tolerability, this additional indication provides a new option for adults who have a partial response to the treatment of an antidepressant.
In addition to being approved as an adjunctive therapy to antidepressants for MDD in adults, it is FDA-approved to treat adults with depressive, acute manic, and mixed episodes associated with bipolar I disorder and schizophrenia.
Cariprazine is co-developed by AbbVie and Gedeon Richter Plc.
A Phase 3 Study 3111-301-001 showed a clinically and statistically significant change from baseline to week six in the depression score for patients treated with cariprazine at 1.5 mg/day + antidepressant monotherapy (ADT) compared with placebo + ADT.
A second registration-enabling study, RGH-MD-75, showed a clinically and statistically significant change from baseline to week eight in the depression score for patients treated with cariprazine at 2-4.5 mg/day (mean dose 2.6 mg) + ADT compared with placebo + ADT.
Price Action: ABBV shares closed lower by 1.61% at $160.48 on Friday.
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