Olanzapine (Zyprexa) approved by FDA to treat schizophrenia in adolescents

Olanzapine (Zyprexa) has been approved 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 in US.

US FDA approval of olanzapine (Zyprexa) for adolescents came after 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.

Eli Lilly had submitted findings from two pivotal clinical trials for the approval: 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.

However, US FDA alerts 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.

Olanzapine (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 olanzapine (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, Eli Lilly stated in a press statement.

Schizophrenia affects about 1 percent of people in US. 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. Studies have suggested that early-onset schizophrenia is associated with worse long-term outcomes compared to onset of illness in adulthood.

Bipolar disorder has an estimated prevalence of 0.1 percent to 2 percent among adolescents. It affects approximately 5.7 million American adults, or about 2.6 percent of the U.S. population age 18 and older.It has an estimated prevalence of 0.1 percent to 2 percent among adolescents.

Lifetime prevalence of bipolar I disorder in community samples has varied from 0.4 percent to 1.6 percent. 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. Early onset of bipolar disorder is associated with greater severity of illness and more functional impairment.

Zyprexa is indicated in adults in the United States for the treatment of schizophrenia, acute treatment of mixed and manic episodes of bipolar I disorder, and maintenance treatment of bipolar I disorder.

Olanzapine (Zyprexa) is indicated for the treatment of schizophrenia and manic or mixed episodes associated with bipolar I disorder in adolescents 13 to 17 years of age. When deciding among alternative treatments available for adolescents, clinicians should consider the increased potential for weight gain and hyperlipidemia compared to adults.

Clinicians should consider the potential long-term risks when prescribing to adolescents, and in many cases this may lead clinicians to consider prescribing other drugs first in adolescents.

Olanzapine (Zyprexa) is not approved for the treatment of patients with dementia-related psychosis. Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death.

In addition, compared to elderly patients with dementia-related psychosis taking a placebo, there was a significantly higher incidence of cerebrovascular adverse events (e.g. stroke, transient ischemic attack) in elderly patients with dementia-related psychosis treated with olanzapine.

The possibility of a suicide attempt is inherent in schizophrenia and bipolar I disorder. Close supervision of high-risk patient should accompany drug therapy.

Potential consequences of weight gain should be considered prior to starting olanzapine. Patients receiving olanzapine should receive regular monitoring of weight. Eli Lilly alerts.

Compared to patients from adult clinical trials, adolescents were likely to gain more weight, experience increased sedation, and have greater increases in total cholesterol, triglycerides, LDL cholesterol, prolactin and hepatic transaminase levels.

Lilly is headquartered in Indianapolis.