Regulatory Focus™ > News Articles > NICE Plans to Recommend Abilify for Treatment of Bipolar Disorder in Children

NICE Plans to Recommend Abilify for Treatment of Bipolar Disorder in Children

Posted 07 June 2013 | By Louise Zornoza

The UK's National Institute for Health and Care Excellence (NICE) has issued draft guidance proposing to recommend aripiprazole (Abilify, Otsuka Pharmaceuticals Europe), for treating moderate to severe manic episodes in adolescents aged 13 and older with bipolar I disorder.

In 2006, NICE published clinical guidelines on the overall management of bipolar disorder in adults, children and adolescents, noting concerns that "the evidence for drug and psychological treatments of bipolar disorder in children and adolescents is ... extremely limited." 

Abilify has been authorized in the EU since June 2004 for the treatment of schizophrenia and for the treatment and prevention of manic episodes in bipolar I disorder. Though it is approved to treat adults, the European Medicines Agency (EMA) has only licensed the drug for use in young people aged 15-17 years. NICE's overall bipolar guidance, however, references a recommendation from the Royal College of Paediatrics and Child Health that "unlicensed medicines may be prescribed for children and adolescents where there are no suitable alternatives and where the use is justified by a responsible body of professional opinion."

Abilify is a partial dopamine agonist, and is an antipsychotic drug with additional antidepressant qualities. It has been approved for the treatment of schizophrenia, bipolar disorder and depression as an add-on treatment when the main antidepressant is not effective enough. It uses a different mechanism from other drugs that have been approved for the same symptoms. The majority of antipsychotics shut down dopamine receptors, whereas Abilify works by activating them, but less strongly than neurotransmitters.

Professor Carole Longson, director of NICE's Centre for Health Technology Evaluation, explained the impact of the adolescent manic episode approval in England and Wales: "Acute manic episodes not only have a huge impact on the young person in terms of school, work and social life, but also on those around them - particularly their family or carers," she said. "Because of this it is really important that manic episodes are treated quickly and effectively so that young people and their families can return to normal in terms of schooling, work and family life as quickly as possible."

Professor Longson continued: "As aripiprazole works at least as well as the existing treatment, our independent appraisal committee now recommends it as an option for treating moderate to severe manic episodes in adolescents with bipolar I disorder." The independent Committee decided that an appraisal consultation document was not needed for this appraisal, so the recommendations could go straight to final draft or final appraisal determination. This happens when the Committee recommends a treatment in line with its licensed indication. The draft guidance is now with consultees, who have the opportunity to appeal against it.


NICE: Bipolar disorder (children) - aripirazole: final appraisal determintation

Read all Breaking News from RegLink

Regulatory Focus newsletters

All the biggest regulatory news and happenings.