BRIEF—Fourth FDA nod for AbbVie's Vraylar

The US Food and Drug Administration (FDA) on Friday approved AbbVie’s Vraylar (cariprazine) as an adjunctive therapy to antidepressants for the treatment of 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.

Vraylar generated net revenues of $554 million in third-quarter 2022, a year-on-year increase of 20.2%.

Of note, this is Vraylar’s fourth indication for treating mental illness, as it is also FDA-approved to treat adults with depressive, acute manic and mixed episodes associated with bipolar I disorder, as well as schizophrenia.

Vraylar generated net revenues of $554 million in third-quarter 2022, a year-on-year increase of 20.2%.

"Many living with major depressive disorder find that their ongoing antidepressant therapy doesn't offer meaningful relief from the symptoms they experience every day," said Dr Thomas Hudson, senior vice president R&D and chief scientific officer, AbbVie.

MDD is one of the most common mental disorders in the USA; approximately one in five adults will experience this disorder during their lifetime.