October 13, 2008
Lev Pharmaceuticals Wins Approval for Angioedema Drug
Lev Pharmaceuticals, a biopharmaceutical company, has received the FDA's approval for 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 hereditary angioedema (HAE) later in 2008.A program will be offered to provide support services such as benefit coverage investigations, prior authorizations and broad-based reimbursement assistance for patients and healthcare providers. This program will also assist patients and healthcare providers by helping to secure adequate insurance coverage for Cinryze C1 inhibitor. The company is committed to assuring access to Cinryze for all patients who may benefit from therapy.
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 the FDA, Lev has requested the withdrawal of the portion of the application referring to data for the acute treatment of HAE attacks. This data will be re-submitted as a supplemental biologic license application, 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 the FDA must agree.
Cinryze is said to be the first and only FDA-approved C1 inhibitor therapy for routine prophylaxis against HAE attacks in the US.
Previously, Lev Pharmaceuticals and ViroPharma signed a definitive merger agreement under which ViroPharma will acquire Lev. ViroPharma expects to complete its acquisition of Lev in October 2008. ViroPharma intends to conduct a conference call to discuss the approval and indication of Cinryze after the close of its acquisition of Lev.