Otsuka Pharma and Bristol-Myers Squibb Company (BMS ) announced today that the USFDA approved the supplemental New Drug Application for ABILIFY® (Aripiprazole) for the acute treatment of manic and mixed episodes associated with Bipolar I Disorder, with or without psychotic features in pediatric patients (10 to 17 years old). Aripiprazole has been approved for the acute and maintenance treatment of manic and mixed episodes associated with Bipolar I Disorder with or without psychotic features in adults since September 2004 and March 2005, respectively.
The approval is based on results from a four-week, multicenter, randomized, double-blind, placebo-controlled study in pediatric patients (10 to 17 years old) with Bipolar I Disorder that demonstrated efficacy with ABILIFY compared to placebo on the primary efficacy endpoint, mean change from baseline to Week 4 on the Young-Mania Rating Scale (Y-MRS) Total Score."We are pleased that the FDA has approved ABILIFY to treat pediatric patients aged 10 to 17 years suffering from Bipolar I Disorder," said Taro Iwamoto, Ph.D., Chief Executive Officer, President and Chief Operating Officer, Otsuka Pharmaceutical Development and Commercialization, Inc. "The approval of this new indication for ABILIFY provides clinicians with expanded treatment options that can help address the therapeutic needs of this population."
"We are committed to developing innovative new medicines to their fullest potential," said Elliott Sigal, M.D., Ph.D., Executive Vice President, Chief Scientific Officer and President, Research and Development, Bristol-Myers Squibb. "Expanding the clinical use of an important therapy such as ABILIFY gives pediatric patients with Bipolar I Disorder and their caregivers a new treatment option in their fight against this serious disease."
US 5006528 is listed in orange book for Aripiprazole tablets. The patent will expire on 20 april 2015. This product has also got Pediatric exclusivity which will expire in September 2008. There is one adjunctive treatment exclusivity which will expire in 16 November 2010.
The approval is based on results from a four-week, multicenter, randomized, double-blind, placebo-controlled study in pediatric patients (10 to 17 years old) with Bipolar I Disorder that demonstrated efficacy with ABILIFY compared to placebo on the primary efficacy endpoint, mean change from baseline to Week 4 on the Young-Mania Rating Scale (Y-MRS) Total Score."We are pleased that the FDA has approved ABILIFY to treat pediatric patients aged 10 to 17 years suffering from Bipolar I Disorder," said Taro Iwamoto, Ph.D., Chief Executive Officer, President and Chief Operating Officer, Otsuka Pharmaceutical Development and Commercialization, Inc. "The approval of this new indication for ABILIFY provides clinicians with expanded treatment options that can help address the therapeutic needs of this population."
"We are committed to developing innovative new medicines to their fullest potential," said Elliott Sigal, M.D., Ph.D., Executive Vice President, Chief Scientific Officer and President, Research and Development, Bristol-Myers Squibb. "Expanding the clinical use of an important therapy such as ABILIFY gives pediatric patients with Bipolar I Disorder and their caregivers a new treatment option in their fight against this serious disease."
US 5006528 is listed in orange book for Aripiprazole tablets. The patent will expire on 20 april 2015. This product has also got Pediatric exclusivity which will expire in September 2008. There is one adjunctive treatment exclusivity which will expire in 16 November 2010.
