Another New FDA Indication For Abilify

Implications: The FDA’s approval of Abilify for treatment of acute manic and mixed episodes of pediatric Bipolar Disorder is a very important milestone.   Treatment with Abilify already has had growing off-label use in the pediatric population, in both acute and chronic settings, because of its favorable profile on weight. Now data is here to support that.      

Analysis: This is very good news clinically and also good news commercially for Bristol-Myers Squibb and Otsuka, coming off the Abilify adult depression augmentation approval last November.   Pediatric bipolar disorder presents challenges beyond managing bipolar symptoms; children and adolescents are moving through a complex developmental period and the medical/psychological sequelae of weight gain (sometimes profound) - common to the class of atypical neuroleptics and other bipolar medications such as Depakote - cannot be overstated.   While this FDA indication is for acute mood episodes, maintenance treatment with Abilify is often utilized longer term in this population because of its better side effect/metabolic profile than drugs such as Zyprexa, Risperdal and DKA, among others.   I anticipate Abilify will obtain a maintenance pediatric bipolar indication though the data is not yet available, which should further support its important place in the treatment of bipolar disorder.