Are you sure?

Richterʼs cariprazine wins expanded FDA approval

Hungaryʼs Gedeon Richter and Irish pharmaceutical firm Allergan have announced that the U.S. Food and Drug Administration (FDA) has approved Vraylar (cariprazine) for expanded use to treat depressive episodes associated with bipolar depression in adults.

“This approval represents an important milestone in our efforts to help patients and prescribing healthcare providers effectively manage bipolar I disorder, and demonstrates our ongoing focus on mental health,” said David Nicholson, chief research and development officer at Allergan, cited in a press release sent to the Budapest Business Journal. “We are committed to developing therapies for complex mental health disorders, including Vraylar, which is currently in phase III clinical trials for the treatment of Major Depressive Disorder.”

“This approval is considered a notable achievement in the development process of cariprazine, our flagship product,” said Dr. István Greiner, research director of Gedeon Richter. “We are pleased that more and more patient groups suffering from psychiatric disorders will get access to cariprazine as a treatment option.”

Vraylar is also approved in the United States for the treatment of manic or mixed episodes associated with bipolar I disorder in adults. The press release notes that there are nearly 11 million adults in the U.S. living with bipolar disorder, a condition that causes extreme shifts in mood, energy, and activity levels.

Cariprazine was Richterʼs third best-selling drug last year, after contraceptives and the nootropic Cavinton, state news wire MTI added. Vraylar was discovered and co-developed by Gedeon Richter and is licensed by Allergan in the U.S. and Canada.