BMS takes first step with Abilify sNDA

Bristol-Myers Squibb (BMS) and Otsuka Pharmaceuticals saw their supplemental New Drug Application (sNDA) for Abilify accepted by the US Food and Drug Administration today.

Now accepted for filing, the application will be granted priority review for the treatment of paediatric patients (aged 10 to 17) with Bipolar I Disorder – manic or mixed episode with or without psychotic features.

Priority review is only assigned if a product, if approved, could represent an improvement compared to other products on the market.

This includes non-drug products and therapies in the treatment, diagnosis and prevention of a disease.

The sNDA is based on data from a study which saw two fixed oral doses of Abilify administered to 296 paediatric patients with Bipolar I Disorder over 30-weeks.

Abilify’s safety and efficacy profile was assessed with both 10mg/day and 30mg/day doses.

The FDA states that it attempts to review a product within six months of granting it priority review.

Earlier this month BMS and Otsuka Pharmaceutical announced that the FDA had approved its supplemental New Drug Application for Abilify a in the treatment of schizophrenia in adolescents from 13 to 17 years.