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FDA Advisory Committee Supports Efficacy and Safety of Zyprexa(R) Long-Acting Injection (LAI) for Schizophrenia Treatment
Date:2/6/2008

INDIANAPOLIS, Feb. 6 /PRNewswire-FirstCall/ -- The U.S. Food and Drug Administration's (FDA) Psychopharmacologic Drugs Advisory Committee voted that, with appropriate labeling around excessive sedation events, Zyprexa(R) long-acting injection (olanzapine LAI) has been shown to be effective and acceptably safe for the treatment and maintenance treatment of schizophrenia in adults, Eli Lilly and Company (NYSE: LLY) announced today.

Zyprexa LAI is an investigational formulation that combines the atypical antipsychotic medication Zyprexa (olanzapine) with a pamoate salt, resulting in an extended delivery of up to four weeks.

"A primary barrier to the successful treatment of schizophrenia, a chronic and devastating illness, is that patients often relapse because they have trouble taking their medication on a regular basis," said Dr. John Kane, chairman, Department of Psychiatry, The Zucker Hillside Hospital, Glen Oaks, N.Y. "Long-acting injectable antipsychotics can help patients derive more consistent benefits from their medications."

John Hayes, M.D., vice president of Lilly Research Laboratories, said, "Due to the chronic and severe nature of the illness and the limited number of approved long-acting formulations, we believe that, if approved, Zyprexa LAI could be an important treatment option for this patient population, who struggle with taking their medication. We are pleased with the committee's recommendation and will continue to work with the FDA in its review of our application."

The committee reviewed data from a comprehensive clinical program comprising eight studies. Results from the clinical trials showed greater symptom improvement in Zyprexa LAI-treated patients, compared with those on placebo. Due to
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