Otsuka Pharmaceutical Co., Ltd. and Bristol-Myers Squibb Company announced that the US Food and Drug Administration (FDA) has accepted for filing and granted a Priority Review to the supplemental New Drug Application (sNDA) of the atypical antipsychotic.

Abilify (aripiprazole) for the treatment of paediatric patients (10 to 17 years old) diagnosed with Bipolar I Disorder, manic or mixed episode with or without psychotic features.

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/therapies in the treatment, diagnosis or prevention of a disease. The FDA goal for reviewing a drug with Priority Review is six months.

This sNDA is based on data from a multicentre, randomised, double-blind, placebo-controlled study of two fixed oral doses of Abilify (10 mg/day or 30 mg/day). The efficacy and safety of Abilify were assessed in 296 ethnically diverse paediatric 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. This trial was sponsored by Otsuka Pharmaceutical Co., Ltd. and its US subsidiary, Otsuka Pharmaceutical Development & Commercialisation, Inc. (Princeton, NJ) and was conducted at 54 centres in the US.

The first and only available dopamine partial agonist, Abilify is indicated for the treatment of acute manic or mixed episodes associated with Bipolar I Disorder in adults. Abilify is also indicated for the treatment of schizophrenia in adults and adolescents (13 to 17 years old). Abilify Injection is indicated for the treatment of adults with agitation associated with schizophrenia or Bipolar I Disorder, manic or mixed.

Initially approved in November 2002, over 12.5 million prescriptions have been written for Abilify in the US through June 2007.

Abilify is indicated for acute and maintenance treatment of schizophrenia in adults. It is indicated for acute and maintenance treatment of adults with manic or mixed episodes associated with Bipolar I Disorder with or without psychotic features

Otsuka Pharmaceutical Co., Ltd. and Bristol-Myers Squibb are collaborative partners in the development and commercialisation of Abilify in the United States and major European countries.