February 3, 2009 / 5:50 PM / 10 years ago

UPDATE 1-ViroPharma genetic disease drug gets fast review

Feb 3 (Reuters) - ViroPharma Inc VPHM.O said U.S. health regulators granted a priority review for its drug Cinryze as a treatment for acute attacks of hereditary angioedema (HAE), a potentially life-threatening genetic disease.

The company said its application to the U.S. Food and Drug Administration was based on a re-analysis and resubmission of data from a late-stage acute treatment study of Cinryze, which is already approved for the preventive treatment of HAE.

HAE is a potentially life-threatening genetic disease, characterized by acute attacks of painful swelling of the skin, intestine, mouth and throat.

The FDA has set a Prescription Drug User Fee Act (PDUFA) target date of June 3, 2009, to reach a decision on Cinryze.

Under the priority review, which is granted to products that are considered to be more advanced over existing therapies, the FDA takes a shorter time, usually six months from the date of submission of the application, to make its decision.

ViroPharma, which gained access to Cinryze through its acquisition of Lev Pharmaceuticals Inc last October, said it submitted a supplemental Biologics License Application to the FDA on Dec. 1, 2008.

Shares of the company were trading up 23 cents at $11.90 Tuesday afternoon on Nasdaq. (Reporting by Anand Basu in Bangalore; Editing by Pratish Narayanan)

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