Dec 4 2009
The U.S. Food and Drug Administration (FDA) today approved Zyprexa® (olanzapine) in tablet form as an option for the treatment of schizophrenia and manic or mixed episodes associated with bipolar I disorder in adolescents aged 13-17 years old.
The updated Zyprexa label states that clinicians should take into consideration the increased potential for weight gain and hyperlipidemia in adolescents compared to adults and the potential for long-term risks, which in many cases, may lead them to consider prescribing other drugs first in adolescents. Compared to patients from adult clinical trials, adolescents were also likely to experience increased sedation and greater increases in prolactin levels and hepatic transaminase (liver enzymes) levels. The recommended starting dose for adolescents is lower than that for adults.
An FDA Psychopharmacologic Drug Advisory Committee (PDAC) met in June and discussed the difficulties of diagnosing and treating these conditions in adolescents. The Zyprexa label provides additional guidance to physicians that medication therapy for pediatric schizophrenia or bipolar I disorder should be initiated only after a thorough diagnostic evaluation and careful consideration of the risks associated with medication treatment.
The updated Zyprexa label also highlights the need for a comprehensive treatment program in pediatric patients and recommends that Zyprexa be used as part of a "total treatment program for pediatric patients with schizophrenia and bipolar I disorder," which may include psychological, educational and social interventions.
This approval follows a favorable vote regarding the safety and efficacy of Zyprexa from the FDA PDAC in June on Lilly's supplemental New Drug Applications for these indications. The Committee examined findings from two pivotal clinical trials: one six-week trial in adolescents with schizophrenia 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."