FDA Advisory Committee Supports Zyprexa For Two Adolescent Indications

FDA’s Psychopharmacologic Drugs Advisory Committee (PDAC) voted that Zyprexa (olanzapine), an atypical antipsychotic, is effective and acceptably safe for the acute treatment of schizophrenia or manic or mixed episodes, associated with bipolar I disorder in adolescents aged 13-17 years old.

The committee examined findings from two pivotal clinical trials of Zyprexa in adolescents with schizophrenia or bipolar I disorder, including a six-week double-blind, placebo-controlled trial to assess the efficacy and safety of Zyprexa in 72 adolescents (aged 13-17 years old) with schizophrenia. The other was a three-week, randomized, double-blind, placebo-controlled trial to assess the efficacy and safety of Zyprexa in 107 adolescents (aged 13-17 years) with acute manic or mixed episodes associated with bipolar I disorder.

In these studies, adolescents taking Zyprexa experienced significant improvements in their schizophrenia and bipolar symptoms on various efficacy measures.

John Hayes, Vice President, Lilly Research Laboratories, said: Today’s Committee vote is an important step toward providing help and hope to the many teens suffering from severe mental illness.