You are here

Aripiprazole Gains Priority Review for the Treatment of Pediatric Patients with Schizophrenia

TOKYO and PRINCETON, N.J., JUNE 5 /PRNewswire/ -- Otsuka Pharmaceutical Co., Ltd., and Bristol-Myers Squibb Company (NYSE:BMY) announced today that the U.S. Food and Drug Administration (FDA) has accepted for priority (six month review target) review the supplemental New Drug Application (sNDA) of the atypical antipsychotic Abilify (aripiprazole) for the treatment of pediatric patients (13-17 years old) with schizophrenia. This sNDA is based on data from a six-week, double-blind, randomized, placebo-controlled study, sponsored by Otsuka Pharmaceutical Co., Ltd., and its U.S. subsidiary, Otsuka Pharmaceutical Development & Commercialization, Inc. (Princeton, NJ) evaluating the use of Abilify in 302 ethnically diverse pediatric patients (ages 13-17) and was conducted at 101 centers in 13 countries.

About Abilify (aripiprazole)
The first and only available dopamine partial agonist, Abilify is indicated for the short- and long-term treatment of schizophrenia including maintaining stability in adults who had been symptomatically stable on other antipsychotic medications for periods of three months or longer and observed for relapse during a period of up to 26 weeks. Abilify is also indicated for the treatment of acute manic and mixed episodes associated with Bipolar I Disorder, and for maintaining efficacy in adults with Bipolar I Disorder with a recent manic or mixed episode who had been stabilized and then maintained for at least six (6) weeks. Physicians who elect to use Abilify for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual. Abilify Injection is indicated for the treatment of agitation associated with schizophrenia or bipolar disorder, manic or mixed.

Source: Otsuka Pharmaceutical and Bristol-Myers Squibb

Recent Headlines

Despite older, sicker patients, mortality rate fell by a third in 10 years
Study finds fewer than half of trials followed the law
WHO to meet tomorrow to decide on international public heath emergency declaration
Study of posted prices finds wild variations and missing data
Potential contamination could lead to supply chain disruptions
Delayed surgery reduces benefits; premature surgery raises risks
Mortality nearly doubled when patients stopped using their drugs
Acasti reports disappointing results for a second Omega-3-based drug
Declining lung cancer mortality helped fuel the progress