* Approved to treat aggression, self injury, tantrums
* Drug indicated as part of treatment program
LOS ANGELES, Nov 20 (Reuters) - The U.S. Food and Drug Administration has approved Bristol-Myers Squibb Co’s (BMY.N) and Otsuka Pharmaceutical Co’s anti-psychotic drug Abilify to treat irritability in pediatric patients with autistic disorder, the companies said on Friday.
The FDA decision allows Abilify to be used in patients aged 6 to 17 for symptoms of aggression toward others, deliberate self injury, temper tantrums and quickly changing moods.
Abilify should be part of a total treatment program that includes psychological, educational and social interventions for children with autistic disorder, the companies said in a statement.
If drug treatment is started, treatment guidelines call for routine assessment and monitoring of patients for the development of metabolic adverse effects, the companies said.
Abilify was approved for the new use based on data from two 8-week studies comparing it to a placebo, the companies said. It previously had been approved to treat depression, bipolar disorder, and schizophrenia, the companies said.
Reporting by Gina Keating; Editing by Richard Chang