The approval is the fourth indication for cariprazine, in addition to ones 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.
In October 2021, Richter announced clinical trial results that advanced its antipsychotic cariprazine, marketed under the brand names Vraylar and Reagila, as a potential adjunctive treatment option for the disorder. AbbVie submitted the supplemental new drug application to the FDA in February.
The United States was Richter's biggest market in Q1-Q3: sales there rose 36% to HUF 117.5 bln. Royalty revenue there linked to Vraylar increased 38% to HUF 98.5 bln.
Cariprazine was Richter's biggest-selling product in Q1-Q3, generating a turnover of HUF 104.3 bln, ahead of oral contraceptives, sales of which came to HUF 98.7 bln.
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