Lev Pharmaceuticals Inc. (LEVP.OB) announced that the U.S. Food and Drug Administration approved Cinryze for routine prophylaxis against angioedema attacks in adolescent and adult patients with hereditary angioedema, also known as C1 inhibitor deficiency. Cinryze is expected to be commercially available for prophylaxis against HAE later this year.
As part of the approval, a post-approval requirement is to 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. Collection and periodic reporting of CMC data also have been requested as a post-approval commitment.
Based on discussions with FDA, Lev said it has requested the withdrawal of the portion of the application referring to data for the acute treatment of HAE attacks. This data will be resubmitted as a supplemental BLA, along with additional data from ongoing open label acute studies of Cinryze, as soon as possible. The company does not believe that an additional study will be required, but FDA must agree.
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