Abilify (aripiprazole), a commonly-prescribed antipsychotic medication used to treat bipolar disorder and schizophrenia, received U.S. Food and Drug Administration (FDA) approval yesterday for use within children for Bipolar I Disorder, and teens with schizophrenia.
The FDA approval was specifically for maintenance treatment of manic or mixed episodes, and as add-on treatment to lithium or valproate, for children ages 10 to 17 who have Bipolar I Disorder, the more severe type of bipolar disorder.
Abilify was recently approved for the acute treatment of manic and mixed episodes associated with Bipolar I Disorder with or without psychotic features in pediatric patients (aged 10-17), in February 2008.
It was also approved by the FDA for the acute treatment of Schizophrenia in adolescents (aged 13-17) in October 2007.
The FDA first approved Abilify for the treatment of manic and mixed episodes associated with Bipolar I Disorder with or without psychotic features in adults in September 2004, and for the treatment of Schizophrenia in adults in November 2002.
The safety and effectiveness of Abilify in pediatric patients with Bipolar Mania were established in a four-week, placebo-controlled clinical trial in 197 pediatric patients (aged 10-17).
The safety and effectiveness of Abilify in adolescents with schizophrenia were established in a six-week, placebo-controlled clinical trial in 202 pediatric patients (aged 13-17). Although maintenance efficacy in these patient populations has not been systematically evaluated, maintenance efficacy can be extrapolated from adult data along with comparisons of Abilify pharmacokinetic parameters in adults and pediatric patients.
There is no body of evidence available to answer the question of how long the adolescent patient treated with Abilify should be maintained. It is generally recommended that responding patients be continued beyond the acute response, but at the lowest dose needed to maintain remission. Periodic reassessment should be conducted to determine the need for maintenance treatment.
The FDA approval for Abilify as an adjunct treatment combined with lithium or valproate was made despite the lack of research that specifically examined Abilify’s safety and efficacy in children. The pharmaceutical company said, however, that “such efficacy and lack of pharmacokinetic interaction between Abilify and lithium or valproate can be extrapolated from adult data along with comparisons of Abilify pharmacokinetic parameters in adult and pediatric patients.”
“We are extremely pleased to receive expanded indications on the use of ABILIFY in these patient populations,” said Taro Iwamoto, Ph.D., Chief Executive Officer, President and Chief Operating Officer, Otsuka Pharmaceutical Development and Commercialization, Inc.
“Expanding the clinical uses of an important therapy such as ABILIFY gives caregivers and pediatric patients with Bipolar I Disorder or Schizophrenia a new treatment option in their fight against serious disease,” said Elliott Sigal, M.D., Ph.D., Executive Vice President, Chief Scientific Officer and President, Research and Development, Bristol-Myers Squibb.
Otsuka Pharmaceutical Co., Ltd. and Bristol-Myers Squibb Company, makers of Abilify, made the announcement yesterday via a press release.
Source: Compiled from a press release issued by Bristol-Myers Squibb