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Allergan's Vraylar Gets FDA Nod for Maintenance Therapy
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Allergan plc 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.
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Allergan's Vraylar Gets FDA Nod for Maintenance Therapy
Allergan plc 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 PLC. Price
Allergan PLC. Price | Allergan PLC. Quote
Zacks Rank
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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And this outperformance has not just been a recent phenomenon. Over the years it has been remarkably consistent. From 2000 - Q1 2017, the composite yearly average gain for these strategies has beaten the market more than 11X over. Maybe even more remarkable is the fact that we're willing to share their latest stocks with you without cost or obligation.
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