13 January 2010 - Swiss biopharmaceutical company Actelion Ltd (VTX: ATLN) said yesterday that the US Food and Drug Administration's (FDA) Endocrinologic and Metabolic Drugs Advisory Committee voted (10 to 3 ) to recommend approval of the supplemental New Drug Application (sNDA) of Zavesca (product,search) for the treatment of Niemann-Pick type C (NP-C) disease.

NP-C disease is a very rare, progressive and eventually fatal neurodegenerative genetic disorder for which no specific treatment is currently approved in the US.

More specifically, the Advisory Committee voted (10 yes to 3 no) in its final vote in question that the benefit/risk profile of Zavesca (miglustat) supports its approval for the treatment of progressive neurological manifestations in adult patients and pediatric patients with NP-C disease.

Zavesca was approved in the European Union (EU) and other countries in 2009. It is also indicated in the US, the EU and other countries for the oral treatment of adult patients with mild to moderate type 1 Gaucher disease for whom enzyme replacement therapy is unsuitable or is not a therapeutic option.

FDA's decision regarding the sNDA is expected in March 2010, the company said.

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