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FDA Advisory Committee Votes in Favor of Zyprexa for Two Adolescent Indications
Date:6/10/2009

ADELPHI, Md., June 10 /PRNewswire-FirstCall/ -- The U.S. Food and Drug Administration (FDA) Psychopharmacologic Drugs Advisory Committee (PDAC) voted that Zyprexa(R) (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 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.

"This Committee of experts spent two days discussing the science of a difficult topic being debated in media, doctors' offices and living rooms across the country," said John Hayes, M.D., vice president of Lilly Research Laboratories. "Today's Committee vote is an important step toward providing help and hope to the many teens suffering from severe mental illness."

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.

For the proposed schizophrenia indication, the panel voted 11-5, with two abstentions, that Zyprexa's effectiveness had been demonstrated, and voted 10-4, with four abstentions, that these data demonstrated acceptable safety. For the proposed indication for manic or mixed episodes associated with bipolar I disorder, the panel voted 17-0, with one abstention, that Zyprexa's effectiveness had been demonstrated, and voted 11-4, with three abstentions, that these data demonstrated acceptable safety.

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-cont
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SOURCE Eli Lilly and Company
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