Richter Peer AbbVie Receives Approval for Expanded Use of Vraylar

Pharma

Image by Richter.hu

Hungarian pharmaceutical company Gedeon Richter on Monday said its U.S. peer AbbVie received a new drug permission from the U.S. Food and Drug Administration for the expanded use of cariprazine for the adjunctive treatment of major depressive disorder, according to a report by news agency MTI.

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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