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Allergan's (AGN) Vraylar sNDA Accepted for Review by FDA

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Allergan plc (AGN - Free Report) announced that its supplemental New Drug Application (sNDA) for its schizophrenia capsules Vraylar has been accepted for review by the FDA.

Allergan is looking to get Vraylar’s label expanded to include new data, which supports the drug’s use as a maintenance treatment.

Allergan’s share price is up 14% this year so far, while the Zacks classified Medical-Generics Drug industry rose 4.4%.

Coming back to Vraylar, the once daily atypical antipsychotic was approved for the acute treatment of manic or mixed episodes associated with bipolar I disorder and for schizophrenia in 2015.   

The sNDA was based on data from a phase III study evaluating Vraylar for the maintenance of efficacy in adults with schizophrenia. Data from the study showed that Vraylar significantly delayed the time to relapse compared to placebo. Moreover, relapse occurred in nearly twice as many placebo patients (47.5%) as compared to those treated with Vraylar.

It has been noticed that schizophrenia patients are at a very high risk of relapse without antipsychotic treatment. Around 60-70% of schizophrenia patients relapse within a year while 90% relapse within two years in the absence of maintenance treatment. Therefore, Vraylar, if approved for maintenance treatment based on the positive long-term efficacy and safety, could access a broader patient population.

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 in 2017.

Other players in the bipolar disorder and schizophrenia treatment market include AstraZeneca plc’ (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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