FDA approves expanded use of Vraylar for bipolar depression
The US Food and Drug Administration has approved a supplemental New Drug Application (sNDA) for Vraylar (cariprazine) for expanded use to treat depressive episodes associated with bipolar I disorder (bipolar depression) in adults.
Vraylar, originated by Hungarian drugmaker Gedeon Richter (RICHT: HB) and licensed to Allergan (NYSE: AGN) for the US and Canadian markets, is also approved in the USA to treat manic or mixed episodes associated with bipolar I disorder in adults. There are nearly 11 million adults in the USA living with bipolar disorder, a condition that causes extreme shifts in mood, energy, and activity levels.
Vraylar has been a major growth driver for Gedeon Richter and news of the label extension saw the firm’s rise as much as 6% yesterday, and a further 2.5% to 15.99 euros this morning.
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