The US Food and Drug Administration (FDA) has granted approval for Eli Lilly’s Zyprexa as a treatment for schizophrenia and manic or mixed episodes associated with bipolar I disorder in adolescents aged 13–17.
The drug does, however, come with a warning that physicians should take extra care in treatment due to the increased potential for weight gain and hyperlipidemia in adolescents and the potential for long-term risks.
Approval follows a favourable vote regarding the safety and efficacy of Zyprexa from the FDA based on a new drug application for the indications placed by Eli Lilly in June.
Positive data was collected 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.
Lilly USA Neuroscience senior medical director Cherri Miner said that there has been a recognised need for additional guidance on treating teens diagnosed with these serious mental illnesses.
“With this information added to our label, we can help physicians make informed treatment decisions,” Miner said.
The updated label also highlights the need for a comprehensive treatment programme and recommends that Zyprexa be used alongside psychological, educational and social interventions.
