Firazyr®: First Subcutaneous Treatment for Acute Attacks of Rare and Serious Swelling Disorder Now Available in Canada

Canadians living with hereditary angioedema now have a new, ready-to-use option available to treat attacks

MONTRÉAL, July 17, 2014 /CNW/ - Shire Canada Inc. ("Shire") announced today the availability of FIRAZYR® (icatibant injection) in Canada for the treatment of acute attacks of hereditary angioedema (HAE) in adults with C1-esterase inhibitor deficiency. Firazyr is the first and only subcutaneous, ready-to-use option available to Canadians living with the rare and serious disorder.

"The approval of FIRAZYR in Canada is a huge step forward for patients living with hereditary angioedema, a complex, unpredictable and potentially life threatening medical condition that can cause patients a lot of anxiety," said Dr. Stephen Betschel, Chair of the Canadian Hereditary Angioedema Network. "With FIRAZYR patients now have an "on demand", easily administered subcutaneous treatment option that they can use quickly at the onset of an attack."

HAE attacks are caused by elevated bradykinin levels that lead to episodes of edema at various body sites, the most serious being swelling of the throat. FIRAZYR blocks bradykinin at the bradykinin B2 receptor, representing a novel subcutaneous administered approach to the treatment of acute HAE attacks.

Following training and initial guidance from a healthcare professional, FIRAZYR may be self-administered or administered by a caregiver. FIRAZYR comes in a ready-to-use, pre-filled syringe that patients can carry with them and self-administer to treat an acute HAE attack with minimal delay.

"We are very excited that FIRAZYR is now available in Canada. It's not always easy to live in constant anticipation of an acute attack, knowing that it can strike at any time and be of varying severity, affecting your quality of life" said Jacquie Badiou, President of Hereditary Angioedema (HAE) Canada. "Having a ready-to-use treatment constitutes an important new option for Canadians living with HAE, to lead a productive life."

Patients in Canada will also have access to the Shire OnePath™ HAE support program, a patient program designed to help coordinate services and support and meet patient needs.


About Hereditary Angioedema
Hereditary angioedema (HAE) is a debilitating rare genetic disease that affects only a few hundred Canadians, approximately one in every 10,000-50,000 people. The most common forms of HAE, Type I and Type II, are caused by genetic mutation that leads to a dysfunction or deficiency in the C1 esterase inhibitor (C1-INH) protein in the body.

The main symptoms of HAE are recurrent, sometimes disfiguring and often painful episodes of acute swelling (edema). The swelling attacks can affect any part of the body, but most commonly occur in the face, gastrointestinal tract, extremities (hands, arms, feet, legs) or genitals.(i),(ii),(iii)  HAE attacks can be unpredictable, painful and potentially life threatening.(i-iii)

HAE can be particularly stressful because patients do not know when attacks will happen; there is no pattern to when attacks may occur or to how serious they might be. They can sometimes occur suddenly and without warning, or can develop gradually over a number of hours.

Given the nature of the condition, HAE can severely impact quality of life, disrupting patients' personal, social and working lives.(iv)

About FIRAZYR
Firazyr is indicated for the treatment of acute attacks of hereditary angioedema (HAE) in adults with C1-esterase inhibitor deficiency.

The active substance, icatibant, is a specific bradykinin B2 receptor antagonist. It represents a novel, subcutaneously-administered approach to the treatment of HAE attacks.

The efficacy of FIRAZYR for the treatment of acute attacks of HAE in adults was established in three Phase III clinical studies.

FIRAZYR is currently approved in 43 countries worldwide, including the European Union, the United States and Canada.

For more information regarding FIRAZYR, please consult the product monograph available here: http://www.shirecanada.com/en/documents/FIRAZYR_PM_EN.pdf.

About Shire OnePath™ HAE Patient Support Program
The Shire OnePath™ Program helps Canadians living with HAE by coordinating services and providing support with regards to access to medication, supplies, self-administration training as well as general help and education.

About Shire
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 Neuroscience, Rare Diseases, Gastrointestinal and Internal Medicine and we are developing treatments for symptomatic conditions treated by specialist physicians in other targeted therapeutic areas, such as Ophthalmology.

www.shire.com

About Shire Canada Inc.
Shire Canada Inc. is a subsidiary of Shire with headquarters located in Montréal (Saint-Laurent), Québec. For more information, please visit www.shirecanada.com.

*FIRAZYR is a registered trademark of Shire Orphan Therapies GmbH

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(i) Bork K, Meng G, Staubach P, et al. Hereditary angioedema: new findings concerning symptoms, affected organs, and course. Am J Med 2006;119(3):267-74.
(ii) Nzeako UC, Frigas E, Tremaine WJ. Hereditary angioedema: a broad review for clinicians. Arch Intern Med 2001;161:2417-2429.
(iii) Wilson DA, Castaldo AJ, Vernon MK, et al. Effects of hereditary angioedema: health-related quality of life, depression, productivity, and social consequences. J Allergy Clin Immunol. 2009;123(Suppl 1):S142.
(iv) Lumry WR; Castaldo A J; Vernon MK et al. The humanistic burden of hereditary angioedema: Impact on health-related quality of life, productivity, and depression. Allergy and Asthma Proceedings 2010;31(5):407-414(8).

SOURCE Shire Canada Inc.

For further information: Brigitte Viel, Shire Canada Inc., 514-787-5114, bviel@shire.com