Allergan plc (AGN - Free Report) along with Hungary’s Gedeon Richter Plc announced that the FDA has approved a supplemental new drug application (sNDA) of its schizophrenia drug, Vraylar (cariprazine). The company seeks the regulatory body’s nod for an expanded patient population. The drug is now approved for the treatment of adults with major depressive episodes related to bipolar I disorder.
Vraylar is already green-lighted 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.
The nod for bipolar depression was based on data from the three pivotal studies on Vraylar namely RGH-MD-53, RGH-MD-54 and RGH-MD-56. Data from all three analyses showed that Vraylar demonstrated a statistical significance as compared to placebo in reducing depressive symptoms associated with bipolar I depression.
Following this win, Vraylar became the first and the only partial agonist approved for both the manic and depressive symptoms of bipolar I disorder. Vraylar is also being investigated in a phase III program for treating major depressive disorder.
Shares of Allergan have inched up 1.4% so far this year versus the industry’s decrease of 7.6%.
Vraylar has performed extremely well since its approval in September 2015 and has delivered sales above expectation in 2016, 2017 and 2018. In the first quarter of 2019, Vraylar generated sales of $143.7 million, having soared 70.3% on a year-over-year basis. The drug has become a key driver of Allergan’s top line.
Bipolar depression is a difficult-to-treat disease with approximately 11 million patients suffering the same in the United States. This approval of the expanded indication will help Allergan gain access to a broader section of subjects and boost sales for this promising drug in the future quarters.
Notably, the bipolar depression market is highly competitive as multiple companies are trying to introduce treatments for the disease. Other players in the bipolar disorder and schizophrenia treatment market include 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 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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