Cinryze Receives FDA Approval for Prophylaxis Against Hereditary Angioedema Attacks
The US Food and Drug Administration (FDA) has approved New York City-based Lev Pharmaceuticals’ Cinryze [C1 inhibitor (human)] for routine prophylaxis against angioedema attacks in adolescent and adult patients with hereditary angioedema (HAE), also known as C1 inhibitor deficiency.
The US Food and Drug Administration (FDA) has approved New York City-based Lev Pharmaceuticals’ Cinryze [C1 inhibitor (human)] for routine prophylaxis against angioedema attacks in adolescent and adult patients with hereditary angioedema (HAE), also known as C1 inhibitor deficiency.
The approval came with a post-approval requirement 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.
Cinryze is the first and only FDA-approved C1 inhibitor therapy for routine prophylaxis against HAE attacks in the US. HAE is characterized by painful, debilitating, and sometimes fatal swelling of the extremities, face, genitals, abdomen, and laryngeal tract. These attacks, which affect an estimated 10,000 people in the US, are often unpredictable and may be spontaneous or precipitated by emotional or physical stress.
Cinryze is a highly purified, pasteurized and nanofiltered plasma-derived C1 inhibitor (human) product that has been used for more than 30 years in Europe to treat patients with C1 inhibitor deficiency.
Lev will soon become a part of ViroPharma Incorporated (Exton, PA) under a merger agreement signed on July 15 of this year.
ViroPharma release
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