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The panel supported the FDA and Lilly's position that if Zyprexa is approved for the two indications, prescribers should consider other treatment options first for adolescent patients.
FDA will consider the panel's recommendations in its review of the supplemental new drug applications that Lilly submitted for Zyprexa. The FDA takes the advice of its Advisory Committees into consideration when deciding whether to approve new indications, but is not bound by their recommendations.
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; and 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, the company said.
John Hayes, vice president of 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."
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