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news.Otsuka Pharmaceutical and Bristol-Myers Squibb have received FDA approval for Abilify for the acute treatment of manic and mixed episodes associated with bipolar I disorder, with or without psychotic features in pediatric patients.
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The approval is based on results from a four-week, multicenter, randomized, double-blind, placebo-controlled study in pediatric patients (10 to 17 years old) with bipolar I disorder that demonstrated efficacy with Abilify compared to placebo on the primary efficacy endpoint, mean change from baseline to week four on the Young-Mania Rating Scale (Y-MRS) Total Score.
Taro Iwamoto, CEO, President and COO, Otsuka Pharmaceutical Development and Commercialization, said: “We are pleased that the FDA has approved Abilify to treat pediatric patients aged 10 to 17 years suffering from bipolar I disorder. The approval of this new indication for Abilify provides clinicians with expanded treatment options that can help address the therapeutic needs of this population.”