FDA approves sNDA for pediatric autism drug ABILIFY

Nov 20 2009

Bristol-Myers Squibb Company (NYSE: BMY) and Otsuka Pharmaceutical Co., Ltd. announced today that the U.S. Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) for ABILIFY^® (aripiprazole) for the treatment of irritability associated with autistic disorder in pediatric patients ages 6 to 17 years, including symptoms of aggression towards others, deliberate self-injuriousness, temper tantrums, and quickly changing moods.

While there is no approved treatment for the core symptoms of autistic disorder, irritability can be an associated behavior of autistic disorder and is manifested as aggression towards others, deliberate self-injurious behaviors, temper tantrums, aggression and quickly changing moods. Behavioral problems such as irritability can be a source of impairment or distress to an individual with autistic disorder.

Pharmacological treatment for pediatric patients with irritability associated with autistic disorder is indicated as part of a total treatment program that includes psychological, educational, and social interventions. The decision to initiate pharmacological treatment in children with irritability associated with autistic disorder should be made between healthcare providers and caregivers only after a thorough diagnostic evaluation and discussion of both the benefits and risks associated with pharmacological treatment. If treatment is initiated, American Psychiatric Association (APA) consensus guidelines recommend routine assessment and monitoring of patients’ weight, waist circumference, blood pressure, fasting plasma-glucose level and fasting lipid profile for the development of metabolic adverse effects.

The approval of ABILIFY for this indication is based on data from two eight-week, randomized, double-blind, placebo-controlled, multi-center, Phase III studies in which ABILIFY, compared to placebo, significantly improved scores on the Irritability subscale of the caregiver-rated Aberrant Behavior Checklist (ABC-I). The ABC-I subscale measured the emotional and behavioral symptoms of irritability in autistic disorder, including aggression towards others, deliberate self-injuriousness, temper tantrums, and quickly changing moods. Participating patients had a Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) diagnosis of autistic disorder, confirmed by the Autism Diagnostic Interview-Revised, and exhibited behaviors such as tantrums, aggression, self-injurious behavior, or a combination of these problems.

The efficacy of ABILIFY^® (aripiprazole) for the maintenance treatment of irritability associated with autistic disorder has not been evaluated. While there is no body of evidence available to answer the questions of how long the patient treated with ABILIFY should be maintained, patients should be periodically reassessed to determine the continued need for maintenance treatment.

SOURCE Otsuka Pharmaceutical Co., Ltd. and Bristol-Myers Squibb