Otsuka Pharmaceutical Co., Ltd.

September 28, 2016

Antipsychotic ABILIFY Gains Approval in Japan for the Additional Indication of Irritability Associated with Pediatric Autism Spectrum Disorder

  • For the Otsuka-discovered antipsychotic ABILIFY this is the fourth approved indication after schizophrenia, manic or mixed episodes associated with bipolar I disorder, and as adjunct therapy for major depressive disorder in patients who respond inadequately to antidepressant therapy.
  • It is reported there are approximately 100,000 patients in Japan with autism spectrum, which in some cases can manifest as episodes of aggression, temper tantrums, self-harm, and other behavioral symptoms. For these symptoms few treatment options exist.
  • ABILIFY received approval from the U.S. FDA in 2009 for use in pediatric patients with irritability associated with autism disorders and in Japan three medical societies active in the field of autism specified the high medical need and expectation for the development of new medicines for autism.

Otsuka Pharmaceutical Co., Ltd. on September 28, 2016 obtained regulatory approval in Japan of the antipsychotic drug ABILIFY tablet (generic name aripiprazole) for the additional indication of irritability associated with pediatric autistic spectrum.
In addition regulatory approval was granted for ABILFY tablet in a new, 1mg starting dosage form.