UPDATE 1-FDA to review Actelion's Zavesca for additional use

Thu Nov 19, 2009 1:57am EST

* Zavesca, or miglustat, granted priority review by FDA

* To be reviewed for treatment of NP-C in Jan, 2010

* Zavesca already approved in U.S. to treat Gaucher disease

(Adds details)

ZURICH, Nov 19 (Reuters) - Actelion Ltd (ATLN.VX), Europe's largest biotech company, said on Thursday the U.S. Food and Drug Administration (FDA) would review use of its drug Zavesca to treat a rare neurodegenerative disease early next year.

The FDA has granted priority review for Zavesca, or miglustat, to treat the progressive neurological manifestations in adults and children with Niemann-Pick type C disease (NP-C).

"Miglustat could become the first treatment for NP-C in the USA, which would represent a major therapeutic breakthrough for patients and their treating physicians," Actelion Chief Executive Jean-Paul Clozel said.

The Endocrine and Metabolic Drug Advisory Committee will review the supplemental new drug application on Jan 12, 2010, Actelion said in a statement.

Zavesca is already approved for the oral treatment of adult patients with mild to moderate type 1 Gaucher disease in the United States.

Actelion is trying to cut its dependence on key drug Tracleer, which treats a rare heart and lung disorder and rakes in more than $1 billion a year. (Reporting by Katie Reid; Editing by Hans Peters)

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