UPDATE 1-US clears Lev Pharma drug for rare swelling disease

Fri Oct 10, 2008 5:56pm EDT

(Adds FDA and company comment, background)

WASHINGTON Oct 10 (Reuters) - U.S. health regulators have approved Lev Pharmaceuticals Inc's LEVP.OB experimental drug to treat a rare genetic disease that causes swelling of the hands, feet and other parts of the body.

The drug, called Cinryze, aims to treat hereditary angioedema, a spontaneous and potentially deadly disorder that can be triggered by stress, surgery or infection, the U.S. Food and Drug Administration said in a statement on Friday.

ViroPharma Inc VPHM.O has agreed to buy Lev in a $443 million deal expected to be completed by the end of the year.

Hereditary angioedema disease also can cause swelling of the airway and larynx, which can make it impossible for those experiencing it to breathe and cause asphyxiation, the FDA said.

Up to 10,000 people in the United States have the condition, according to the agency.

Lev's intravenous drug, a protein made from human plasma, is given every three or four days to help prevent swelling, it added.

"Cinryze should greatly enhance treatment options for those with hereditary angioedema and potentially save lives," Dr. Jesse Goodman, head of the FDA's Center for Biologics Evaluation and Research, said.

The drug should be available for patients later this year, Lev said in a statement.

Company studies show Cinryze reduces the frequency of attacks or prevents them in most patients, the company said. Common side effects include rash near the injection site and lightheadedness.

The drugmaker is working to ensure that health insurers cover the product, it added.

Before the FDA announcement, shares of Lev rose more than 8 percent to close at $2.38 while shares of ViroPharma closed up 0.8 percent at $9.57. (Reporting by Susan Heavey; Editing by Tim Dobbyn and Carol Bishopric)

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