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FDA Approves Lilly's Zyprexa for Two Adolescent Indications
Date:12/4/2009

izophrenia and one three-week trial in adolescents with manic or mixed episodes associated with bipolar I disorder, as well as extensive Zyprexa safety data relevant to adolescents.

"There has been a recognized need in the mental health community for additional guidance on treating teens diagnosed with these serious mental illnesses," said Cherri Miner, M.D., Lilly USA Neuroscience Senior Medical Director. "Customers have been asking for data from controlled studies in these populations, and now with this information added to our label, we can help physicians make informed treatment decisions."

About Schizophrenia in Adolescents

Schizophrenia affects about 1 percent of Americans.(1) A substantial portion of first psychotic breaks for schizophrenia occur in adolescence. It has been estimated that 39 percent of males and 23 percent of females with schizophrenia experience onset of the disease before the age of 19.(2) Studies have suggested that early-onset schizophrenia is associated with worse long-term outcomes compared to onset of illness in adulthood.(3)

About Bipolar Disorder in Adolescents

Bipolar disorder affects approximately 5.7 million American adults, or about 2.6 percent of the U.S. population age 18 and older, in a given year.(4) It has an estimated prevalence of 0.1 percent to 2 percent among adolescents.(5) Lifetime prevalence of bipolar I disorder in community samples has varied from 0.4 percent to 1.6 percent.(6) It has been estimated that 20 percent of all patients with bipolar disorder experience their first episode during adolescence, with the peak age of onset for this group of patients occurring between 15 and 19 years of age.(7) Early onset of bipolar disorder is associated with greater severity of illness and more functional impairment.(8)

Safety Information for Zyprexa (olanzapine)

Zyprexa is indicated in adults in the U
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SOURCE Eli Lilly and Company
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