Otsuka Pharmaceutical Co Ltd. announced
that Otsuka Pharmaceutical Co., Ltd. has submitted an application for regulatory approval in Japan of the
anti-psychotic drug ABILIFY (generic name is aripiprazole) for the additional indication of excitability
associated with autistic disorder for juveniles from ages 6 through 17.
An application has been filed with regulatory authorities in Japan for the approval of an
additional indication for the antipsychotic ABILIFY, which has been prescribed in Japan
since 2006. The additional indication sought for ABILIFY is for excitability associated
with autism in juveniles. The prevalence of autism in Japan is between 2 and 20 people per 10,000, and the total
number of patients is reported as approximately 21,000. Few treatment options exist for
the excitability that occurs in about 20% of people with autism and new treatment agents
that can be safely used for it are eagerly awaited.
ABILIFY received approval from the U.S. FDA in 2009 for use in patients with
excitability associated with autism 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.
