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Allergan Eyes Vraylar Label Expansion, FDA Accepts sNDA

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Allergan Eyes Vraylar Label Expansion, FDA Accepts sNDA

FDA accepts Allergan's (AGN) sNDA for label expansion of its schizophrenia drug, Vraylar (cariprazine) to include treatment of bipolar depression.

Allergan AGN announced that the FDA has accepted its supplemental new drug application (sNDA) for approval of its schizophrenia drug, Vraylar (cariprazine) for an expanded patient population. The sNDA is seeking approval of Vraylar for the treatment of adults with major depressive episodes related to bipolar I disorder.

Notably, Vraylar is already approved in the United States and the EU for acute therapy of manic or mixed episodes associated with bipolar I disorder as well as for schizophrenia. If approved for bipolar depression, Vraylar would become the first and only partial agonist approved for both the manic and depressive symptoms of bipolar I disorder.

The sNDA was based on positive data from three pivotal studies on the candidate, RGH-MD-53, RGH-MD-54 and RGH-MD-56. Data from all the three studies demonstrated superiority of Vraylar to placebo in reducing depressive symptoms associated with bipolar I depression.

So far this year, Allergan’s shares have outperformed the industry. Allergan’s shares have risen 16.5% in the period compared with 4.9% increase for the industry.



Vraylar performed well in first half of 2018, recording sales of $198.6 million and rising more than 65% year over year. It has become a key driver of Allergan’s top line.

Bipolar depression is a difficult-to-treat disease with approximately 5 million patients suffering from it. Hence, approval of the drug for the expanded indication will provide Allergan access to a wider patient population that suffers from bipolar issues and thereby boost sales of the drug.

Other players in the bipolar disorder and schizophrenia treatment market include AstraZeneca plc's AZN Seroquel XR, Johnson & Johnson's JNJ Risperdal Consta and Alkermes plc's ALKS Aristada.

Allergan currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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