Lev Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) approved Cinryze™ (C1 inhibitor [human])

Cinryze is used for routine prophylaxis against angioedema attacks in adolescent and adult patients with hereditary angioedema (HAE), also known as C1 inhibitor deficiency. Cinryze is expected to be commercially available for prophylaxis against HAE later this year.

Cinryze is the first and only FDA-approved C1 inhibitor therapy for routine prophylaxis against HAE attacks in the U.S. 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 U.S., are often unpredictable and may be spontaneous or precipitated by emotional or physical stress.

“Until now, living with HAE has been a life-altering, constraining, and truly debilitating experience,” said Michael Frank, MD, professor, Pediatric Allergy and Immunology Division, Duke University School of Medicine. “The approval of this therapy – which has been shown to safely decrease HAE attacks in these patients – represents the potential for patients to live a more normal life.”

“With this approval, patients with HAE will have access to a therapy that helps reduce the frequency and severity of debilitating and potentially life-threatening HAE attacks, said Joshua Schein, chief executive officer of Lev. “Cinryze can help these patients live healthier, more productive and predictable lives.”

A program will be offered to provide support services such as benefit coverage investigations, prior authorizations and broad-based reimbursement assistance for patients and health care providers. This program will also assist patients and health care 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.