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FDA Issues a Complete Response Letter for Lilly's Olanzapine LAI for Treatment of Schizophrenia in Adults
Date:1/7/2009

INDIANAPOLIS, Jan. 7 /PRNewswire-FirstCall/ -- Eli Lilly and Company (NYSE: LLY) announced today that it received a complete response letter from the U.S. Food and Drug Administration (FDA) for olanzapine long-acting injection (LAI) for acute and maintenance treatment of schizophrenia in adults. Lilly is continuing to work with the agency on the new drug application (NDA).

The FDA does not require any additional clinical trials for the continued review of the NDA. Per the agency's request, Lilly is preparing a proposed Risk Evaluation and Mitigation Strategy (REMS), which will be submitted in the near future.

"We cannot speculate on the timing of a potential decision, but remain confident that, if approved, the long-acting depot formulation of olanzapine will offer an important option for treating this devastating and chronic illness," said Todd Durell, M.D., associate medical director for U.S. neuroscience for Lilly.

This treatment has been approved for use in the European Union and New Zealand under the trade name Zypadhera(TM). Independent regulatory reviews are ongoing in other countries.

Notes for editors:

About Long-acting Injectable Antipsychotic Medications

The World Federation of Societies of Biological Psychiatry (WFSBP) guidelines state that poor or partial treatment compliance is a major problem in the long-term treatment of schizophrenia. Depot formulations should be considered as a treatment option if it is determined that a depot formulation is necessary to help with compliance.(1)

By administering long-acting medications, healthcare professionals know when patients have received their medication and can immediately detect non- adherence when a patient fails to return for a scheduled injection.(2) Different from both oral and in
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SOURCE Eli Lilly and Company
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