First and Only Treatment Approved in Canada
for Routine Prevention of Attacks
of a Rare Swelling Disorder
MONTRÉAL, March 23, 2016 /CNW Telbec/ - Shire Pharma Canada ULC ("Shire Canada") today announced that CINRYZE is now available in Canada to patients with hereditary angioedema (HAE) who may benefit from routine prevention. CINRYZE is the first and only treatment in Canada with an approved indication for routine prevention against angioedema attacks in adolescent and adult patients with HAE; a rare and potentially life-threatening genetic disorder that causes acute swelling attacks in different parts of the body.
The Canadian Blood Services (CBS) will distribute CINRYZE throughout the country, except for Québec. Shire Canada is actively working to provide HAE patients in Québec with timely access to CINRYZE, like all other Canadians.
"The launch of CINRYZE in Canada marks yet another important milestone that further strengthens our commitment to Canadians living with HAE," said Eric Tse, Shire Canada General Manager. "Shire is now able to provide Canadians with a portfolio of two complementary treatments for HAE: CINRYZE and FIRAZYR®**."
Canadians prescribed CINRYZE by their physician for the prevention of their HAE attacks are eligible to enroll in the Shire OnePath®*** Patient Support Program to access services designed to train patients to prepare and self-infuse CINRYZE, among other services.
"HAE often takes a physical and emotional toll on patients and their families, which is why it is essential that people living with the condition have access to treatment options that best meet their individual needs," mentioned Jacquie Badiou, HAE Canada President. "The fact that Canadians with HAE have access to yet another Health Canada approved treatment option marks an important step forward in providing more choices for the Canadian HAE community to improve their quality of life."
HAE is a rare condition that affects approximately 1 in 50,000 individuals,i,ii or approximately 720 Canadians.iii The swelling episodes caused by HAE do not follow a typical pattern, which means individuals living with the condition can never predict the onset nor body site of the next attack. The frequency, duration and severity of the edema vary considerably. Untreated patients with HAE can lose 100 to 150 work days per year, if not moreiv.
*CINRYZE is a registered trade-mark of ViroPharma Biologics, Inc.
**FIRAZYR is a registered trademark used under licence from Shire Orphan Therapies GmbH
***ONEPATH is a registered trademark of Shire Human Genetic Therapies, Inc.
CINRYZE is a highly purified, pasteurized and nanofiltered plasma-derived C1 esterase inhibitor product administered intravenously. CINRYZE is approved in Canada for routine prophylaxis (prevention) against angioedema attacks in adolescent and adult patients with HAE.
The most common adverse reaction observed following CINRYZE infusion in clinical studies was rash. 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.
For more information about CINRYZE, please consult the product monograph available here: http://www.shirecanada.com/en/PDF/CINRYZE_PM_EN.pdf.
About Hereditary Angioedema (HAE)
HAE is a debilitating, potentially life-threatening disease characterized by painful, unpredictable, recurrent attacks of swelling and/or edema affecting the hands, feet, face, abdomen, urogenital tract, and the larynx.
For more information on HAE, visit the HAE Canada website at http://www.haecanada.org.
Shire enables people with life-altering conditions to lead better lives.
Our strategy is to focus on developing and marketing innovative specialty medicines to meet significant unmet patient needs.
We provide treatments in Rare Diseases, Neuroscience, Gastrointestinal, and Internal Medicine and we are developing treatments for symptomatic conditions treated by specialist physicians in other targeted therapeutic areas, such as Ophthalmics.
About Shire Pharma Canada ULC
Shire Canada is a subsidiary of Shire with headquarters located in Montréal (Saint-Laurent), Québec. For more information, please visit: www.shirecanada.com.
i Bowen T, Brosz J, Brosz K, et al. Management of hereditary angioedema: 2010 Canadian approach. Allergy, Asthma & Clinical Immunology 2010;6:20.
ii Zuraw BL. Clinical practice. Hereditary angioedema. N Engl J Med. 2008;359(10):1027-1036.
iii Statistics Canada. Canada's population estimates, third quarter 2015. http://www.statcan.gc.ca/daily-quotidien/151216/dq151216e-eng.htm. Accessed Feb 18, 2016.
iv HAE Canada website. What is HAE? http://www.haecanada.org/about-hae/what-is-hae/. Accessed Feb 18, 2016.
SOURCE Shire Pharma Canada ULC
Image with caption: "Logo: Shire Pharma Canada ULC (CNW Group/Shire Pharma Canada ULC)". Image available at: http://photos.newswire.ca/images/download/20160323_C6813_PHOTO_EN_649536.jpg
For further information: Brigitte Viel, Shire Pharma Canada ULC, [email protected], 514-787-5114