Lev Pharma wins FDA approval for Cinryze

Lev Pharmaceuticals has won FDA approval to market Cinryze to treat hereditary angioedema, a potentially lethal genetic disorder characterized by a swelling of the hands, feet or some other body part. Up to 10,000 people in the U.S. have the disease. And Lev says it will make the drug available later this year. The biotech company will also conduct a clinical study designed to evaluate safety, including thrombotic adverse events, efficacy and immunogenicity of higher than labeled doses of Cinryze for routine prophylaxis.

"We are ecstatic that the U.S. HAE community will finally have access to a safe and effective HAE therapy," said Anthony J. Castaldo, president of the U.S. Hereditary Angioedema Association. "Today's approval addresses a longstanding, catastrophic unmet medical need with a therapy that save lives and helps patients overcome the devastating burden posed by this debilitating and life-threatening disease."

The announcement is also good news for ViroPharma, which agreed to acquire Lev last July 15 in a $443 million deal.

- view the Lev Pharma release
- read the story from RTT News

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