ViroPharma Incorporated, an international biopharmaceutical company, announced that the Health Canada has granted a Notice of Compliance (NOC) and approved a New Drug Submission (NDS) for Cinryze (C1 inhibitor [human]). Approval of Cinryze was granted for routine prevention of angioedema attacks in adult and adolescents with hereditary angioedema (HAE).
Until now, there have been no approved plasma derived C1 inhibitor therapies for routine prevention of HAE attacks in Canada. ViroPharma's Canadian headquarters are located in Oakville, Ontario. We anticipate Cinryze to be commercially available in Canada as early as the second quarter of 2013.
Cinryze is a highly purified, pasteurized and nanofiltered plasma-derived C1 esterase inhibitor product. In the US and Canada, Cinryze is approved for routine prophylaxis (prevention) against angioedema attacks in adolescent and adult patients with HAE. In the EU, the product is approved for the treatment and pre-procedure prevention of angioedema attacks in adults and adolescents with hereditary angioedema (HAE), and routine prevention of angioedema attacks in adults and adolescents with severe and recurrent attacks of hereditary angioedema (HAE), who are intolerant to or insufficiently protected by oral prevention treatments or patients who are inadequately managed with repeated acute treatment. Cinryze is for intravenous use only.
"Hereditary angioedema is a complex and life threatening disease that must be managed carefully by physicians," said Dr Tom Bowen, clinical professor of medicine and paediatrics at the University of Calgary. "The approval of Cinryze to help prevent HAE attacks provides an essential addition to the patient care arsenal of physicians across Canada. Disease management options that provide choices for patients for both treatment and prevention of hereditary angioedema can help patients reach their own personal health and wellness goals."
"It is important to have a number of disease management options available for those living with hereditary angioedema," said Della Cogar, founder, HAE Canada. "Hereditary angioedema is a potentially fatal disease that affects patients and their families throughout their lives, and is often passed on from generation to generation. This important addition of Cinryze as the first and only approved preventative option for patients with HAE is wonderful news for families living with the disease, and the physicians who help them manage it."
HAE is a rare, debilitating and potentially life-threatening genetic disorder estimated to affect up to 3,400 people across Canada. HAE is a variable disease, and patients can experience unpredictable, recurrent and disabling attacks of swelling that can affect the upper airway, abdomen, face, extremities and urogenital tract due to a deficiency of C1 inhibitor, a human plasma protein that prevents swelling.
"The approval of Cinryze by Health Canada marks an important milestone for ViroPharma, and more importantly, for people living with HAE in Canada," said Pamela di Cenzo, ViroPharma's general manager, Canada. "We are thrilled to bring a new medication to the Canadian market that can prevent attacks of hereditary angioedema for patients suffering with this debilitating disease."
Severe hypersensitivity reactions to Cinryze may occur. Thrombotic events have occurred in patients receiving Cinryze, and in patients receiving off-label high dose C1 inhibitor therapy. Monitor patients with known risk factors for thrombotic events. With any blood or plasma derived product, there may be a risk of transmission of infectious agents, e.g. viruses and, theoretically, the CJD agent. The risk has been reduced by screening donors for prior exposure to certain virus infections and by manufacturing steps to reduce the risk of viral transmission including pasteurization and nanofiltration.
ViroPharma Incorporated is an international biopharmaceutical company committed to developing and commercializing novel solutions for physician specialists to address unmet medical needs of patients living with diseases that have few if any clinical therapeutic options.