Otsuka files for additional indication on Abilify in Japan

8 December 2015

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.

This article is accessible to registered users, to continue reading please register for free. A free trial will give you access to exclusive features, interviews, round-ups and commentary from the sharpest minds in the pharmaceutical and biotechnology space for a week. If you are already a registered user please login. If your trial has come to an end, you can subscribe here.

Try before you buy

Free

7 day trial access

Take a Free Trial

All the news that moves the needle in pharma and biotech
Exclusive features, podcasts, interviews, data analyses and commentary from our global network of life sciences reporters.
Receive The Pharma Letter daily news bulletin, free forever.

Become a subscriber

£820

Or £77 per month

Subscribe Now

Unfettered access to industry-leading news, commentary and analysis in pharma and biotech.
Updates from clinical trials, conferences, M&A, licensing, financing, regulation, patents & legal, executive appointments, commercial strategy and financial results.
Daily roundup of key events in pharma and biotech.
Monthly in-depth briefings on Boardroom appointments and M&A news.
Choose from a cost-effective annual package or a flexible monthly subscription

The Pharma Letter is an extremely useful and valuable Life Sciences service that brings together a daily update on performance people and products. It’s part of the key information for keeping me informed

Chairman, Sanofi Aventis UK