Risperdal Gains FDA Approval for Two Adolescent Mental Conditions

August 23, 2007

The FDA approved two supplemental new drug applications for Johnson & Johnson’s (J&J) atypical antipsychotic Risperdal as a short-term treatment for both schizophrenia in adolescents ages 13 to 17 and manic or mixed episodes of bipolar I disorder in children ages 10 to 17.

“This is the first FDA approval of what are known as atypical antipsychotic drugs to treat either of these disorders in the pediatric population,” Thomas Laughren, director of the FDA’s Division of Psychiatry Products, said.

The approval, which was based on two short-term studies testing Risperdal (risperidone) in 430 subjects, follows a July approvable letter for the indications. The company was seeking approval for the treatment of schizophrenia, as well as the short-term treatment of bipolar disorder, both in the approved patient populations.

Risperdal is one of J&J’s top-selling medications, generating over $4 billion in sales during 2006.

No postmarketing studies were attached to the approval. Laughren said a previously agreed to study assessing the metabolic effects of the product in children addressed the FDA’s concerns. The study was part of a commitment J&J agreed to when Risperdal gained approval last year for the treatment of irritability associated with autistic disorder in children ages 5 to 16 years.