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news.Lev Pharmaceuticals has announced that the Blood Products Advisory Committee to the FDA has unanimously voted that there is sufficient evidence of safety and efficacy for the approval of Cinryze for the prophylactic treatment of hereditary angioedema.
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The FDA will review the advisory committee’s recommendations in connection with its consideration of Lev’s biologic license application (BLA).
Joshua Schein, CEO of Lev, said: “The advisory committee’s support for Cinryze represents an important advancement for hereditary angioedema (HAE) patients, caregivers, advocates, and physicians who treat this devastating disease. We look forward to continuing to work with FDA to secure approval of Cinryze in order to serve the patients and families who suffer from HAE.”