Otsuka files for additional indication on Abilify in Japan
Japanese mid-size drugmaker Otsuka Pharmaceutical (TYO: 4768) has submitted an application for regulatory approval in Japan of the anti-psychotic drug Abilify (aripiprazole) for the additional indication of excitability associated with autistic disorder for juveniles from ages six through 17.
The prevalence of autism in Japan is between two and 20 people per 10,000, and the total number of patients is reported as around 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 US Food and Drug Administration 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.
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