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news.Otsuka Pharmaceutical and Bristol-Myers Squibb said that the FDA has accepted granted a priority review to the supplemental new drug application of Abilify, an atypical antipsychotic drug.
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Abilify is used for the treatment of pediatric patients aged 10 to 17 years old and diagnosed with bipolar I disorder, manic or mixed episode with or without psychotic features.
The supplemental new drug application (sNDA) is based on data from a multicenter, randomized, double-blind, placebo-controlled study of two fixed oral doses of Abilify (10mg/day or 30mg/day). The efficacy and safety of Abilify were assessed in 296 ethnically diverse pediatric patients (ages 10 to 17) with bipolar I disorder over a 30-week treatment timeframe, which consisted of a four-week double-blind acute phase, followed by a 26-week double-blind continuation phase.
Priority review status for an application or supplement for a drug product is assigned if a product, if approved, could represent an improvement compared to marketed products, including non-drug products or therapies in the treatment, diagnosis or prevention of a disease.
According to the company, Abilify is the first and only available dopamine partial agonist indicated for the treatment of acute manic or mixed episodes associated with bipolar I disorder in adults.