Allergan plc (AGN - Free Report) announced that the FDA has approved its supplemental New Drug Application (sNDA) for label expansion of its schizophrenia capsule, Vraylar (cariprazine), for maintenance treatment.
Notably, Vraylar is already approved in the United States for acute treatment of schizophrenia and bipolar disorder. It is also approved in Europe for the given indication.
Shares of Allergan have declined 16.9% this year so far, comparing favorably with the industry’s decrease of 31.5%.
The FDA approval was based on new data from a 72-week study in the prevention of relapse in adult patients with schizophrenia. Data from the study demonstrated that long-term treatment with Vraylar delayed time to relapse compared with placebo over the course of up to 72 Weeks.
Significantly, Vraylar has performed above expectations in 2016, recording sales of $94.3 million in the year. The drug is likely to be a key driver of Allergan’s top-line growth in 2017.
Per the company’s press release, approximately 2.4 million people are affected by schizophrenia in the United States. Also, the disease relapses in 60-70% patients within a year if no maintenance treatment is taken. Hence, Vraylar’s label expansion as a maintenance therapy will cater to the hugely unmet need of patients, requiring a long-term treatment option for the disease.
Other players in the bipolar disorder and schizophrenia treatment market are AstraZeneca plc's (AZN - Free Report) Seroquel XR, Johnson & Johnson's (JNJ - Free Report) Risperdal Consta and Alkermes plc's (ALKS - Free Report) Aristada.
Allergan 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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