The FDA has approved Lilly’s 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.
Reportedly, the 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 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.
The FDA Psychopharmacologic Drug Advisory Committee (PDAC) 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.
Cherri Miner, neuroscience senior medical director at Lilly, said: “There has been a recognised need in the mental health community for additional guidance on treating teens diagnosed with these serious mental illnesses.
“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.”