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Astellas Submits NDA For First Restless Leg Syndrome Drug In Japan

This article was originally published in PharmAsia News

Executive Summary

Astellas submitted an NDA Nov. 19 for restless leg syndrome drug ASP8825 with Japan's Ministry of Health, Labor and Welfare

Astellas submitted an NDA Nov. 19 for restless leg syndrome drug ASP8825 with Japan's Ministry of Health, Labor and Welfare.

Licensed from U.S. firm Xenoport in 2005, the drug is developed by GlaxoSmithKline in the U.S. and under FDA review. According to Astellas, there are 3.9 million potential RLS patients in Japan and only 12 percent of these patients are diagnosed. Currently there are no approved RLS drugs in Japan and Nippon Boehringer Ingelheim plans to submit an additional indication of RLS for Parkinson's disease drug Bi-sifrol (pramipexole) next year. (Click here for more - Japanese language)

"Astellas Submits NDA For RLS Drug, Estimates 3.9 Million Potential Patients"--CB News (11/19/2009)

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This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

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