Bristol-Myers Squibb/Otsuka's Abilify gains expanded approval in USA

The already marketed antipsychotic drug Abilify (aripiprazole), from US drug major Bristol-Myers Squibb (NYSE: BMY) and originator Japan’s Otsuka (4768: JP), has received US Food and Drug Administration approval as an adjunct to the mood stabilizers lithium or valproate for the maintenance treatment of Bipolar I Disorder.

Abilify, which generated sales of $2.56 billion for B-MS last year, was approved as an adjunct to lithium or valproate for the acute treatment of manic or mixed episodes associated with Bipolar I Disorder in May 2008. The drug is also approved as monotherapy for the acute treatment of manic or mixed episodes associated with Bipolar I Disorder and for the maintenance treatment of Bipolar I Disorder. Abilify has a boxed warning regarding increased mortality in elderly patients with dementia-related psychosis. Elderly patients treated with antipsychotic drugs are at an increased risk of death. The drug is not approved for the treatment of patients with dementia-related psychosis.

“Patients with Bipolar I Disorder often experience cycles of severe mood swings rather than a single episode,” said John Tsai, vice president, US medical, at B-MS. “Because Bipolar Disorder is a lifelong and recurrent illness, this labeling update provides physicians with the option to prescribe Abilify as an add-on to either lithium or valproate as a long-term treatment to help manage symptoms of Bipolar I Disorder. Patients should be periodically reassessed by their physician to determine the continued need for maintenance treatment,” Dr Tsai added.