Actelion drug granted priority review
19 November 2009 00:00 in Pharmaceutical Company Product News
Actelion has revealed that the Food and Drug Administration (FDA) has granted priority status to its new drug application for Zavesca (miglustat).
The drug, which is designed to treat progressive neurological manifestations in adult and paediatric patients with Niemann-Pick type C disease (NP-C), has been accepted for examination by the FDA.
Now, the FDA will now have to review the application within the coming six months.
It is currently indicated for use in adults with mild to moderate type 1 Gaucher disease where enzyme replacement therapy is unsuitable.
Jean-Paul Clozel, chief executive officer of the firm, commented: "Actelion is working closely with the FDA to provide information as needed to support the review process and make miglustat available [...] to patients suffering from this fatal neurodegenerative genetic disorder affecting both children and adults."
Last month, Actelion published its financial results for the third quarter of the year, displaying net revenues of 1.3 million Swiss francs (784, 823 pounds) - a rise of 22 per cent compared to the correlating period of last year.
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