Pharma major Eli Lilly & Co. (LLY) said Friday, that the company has received the FDA approval for supplemental New Drug Applications or sNDA's for blockbuster drug Zyprexa 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.
FDA has updated label for Zyprexa for clinicians to consider the increased potential for weight gain and hyperlipidemia in adolescents compared to adults and the potential for long-term risks which may lead them to consider prescribing other drugs first in adolescents.
The company said that 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, the company added.
Zyprexa's updated label also highlights the need for a comprehensive treatment program in pediatric patients and recommends that the drug must 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.
Earlier, in June, an FDA Psychopharmacologic Drug Advisory Committee met discussed the difficulties of diagnosing and treating these conditions in adolescents.
The FDA's approval follows a favorable Psychopharmacologic Drug Advisory Committee vote regarding the safety and efficacy of Zyprexa in June on Lilly's sNDA's for these indications. The Committee examined findings from two pivotal clinical trials.
The trials reviewed by the FDA committee include 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.
Zyprexa was approved by FDA in 1996 and was launched in year 2000 for acute bipolar mania and later approved for other indications including for the treatment of schizophrenia and bipolar maintenance.
In April 2004, FDA while approving Zyprexa IntraMuscular for Injection for the treatment of agitation associated with schizophrenia and bipolar I mania, deferred submission of pediatric studies until November 30, 2006.
For the recent third quarter, Zyprexa's revenues rose 3% year-over-year to $1.22 billion from $1.19 billion. Zyprexa's revenue contribute a major part of the company's total revenues compared to the company's other major drugs, for the recent third quarter the company's total revenue was $5.56 billion.
Olanzapine 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.
Bipolar disorder, also known as manic depressive disorder or manic depression is a psychiatric diagnosis that describes a category of mood disorders defined by the presence of one or more episodes of abnormally elevated mood clinically referred to as mania or, if milder, hypomania. Individuals who experience manic episodes also commonly experience depressive episodes or symptoms, or mixed episodes in which features of both.
Schizophrenia is a chronic, severe, and disabling brain disease.
Friday, LLY closed at $37.39, down $0.01 or 0.03% on the NYSE. In the after hours, the shares gained $0.49 or 1.31% to trade at $37.88.
by RTT Staff Writer
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