OTTAWA, ON – CSL Behring Canada announced that HAEGARDA® (C1 Esterase Inhibitor Subcutaneous [Human]), is now available in all of Canada. HAEGARDA is a subcutaneous C1 esterase inhibitor (C1-INH) therapy indicated for routine prevention of Hereditary Angioedema (HAE) attacks in adolescent and adult patients.1 HAE patients have absent or low levels of endogenous or functional C1-INH.1 Administration of HAEGARDA replaces the missing or malfunctioning C1-INH protein in patients with HAE.1 The efficacy and safety of HAEGARDA for routine prophylaxis to prevent HAE attacks were demonstrated in a multicenter, randomized, double-blind, placebo-controlled, crossover study which showed that the median percentage reduction in the number of HAE attacks relative to placebo was 95.1% on 60 IU/kg HAEGARDA.1,2
“Hereditary Angioedema (HAE) is a rare disease that results in unpredictable, painful swelling of various body parts which may be potentially life threatening. As a physician that treats this disease, I’m pleased to have HAEGARDA available for patients across Canada. HAEGARDA represents another needed therapeutic advancement for the prevention of HAE as the only Subcutaneous C1 Inhibitor for preventative therapy approved in Canada,” said Dr. Stephen D Betschel, Clinical Immunologist and Allergist, St. Michael’s Hospital, Toronto.
HAE is caused by deficient or dysfunctional C1-INH, a protein in the blood that helps to control inflammation, and causes the edema attacks associated with the disease. Depending on the severity of the disease, patients could experience several debilitating attacks each month. Laryngeal attacks, which are experienced by more than half of all HAE patients during their lifetime block the airway and can be fatal – with mortality rates as high as 33 percent in untreated patients3,4,5.
HAE Canada commented on the HAEGARDA availability in this statement: “HAE Canada President, Jacquie Badiou, COO, Daphne Dumbrille, and the Board of Directors, are excited that at long last, HAEGARDA is now equally available, without restrictions, to adolescent and adult HAE patients across Canada. This represents yet another milestone for the advancement of care for Canadian HAE patients who need a subcutaneous C1 esterase inhibitor therapy.”
CSL Behring Canada also assists patients to get access to training for the administration of HAEGARDA® via the CSL Behring PLUS+ program that offers services and educational materials. Patients can ask their Healthcare professionals to enroll them in the program at any time.
For more information and a complete risk/benefit profile, please contact Customer Service at 1-866-773-7721 ext. 2386 or refer to the Product Monograph available on CSL Behring website at https://www.cslbehring.ca/products/product-list
About Hereditary Angioedema
HAE is a rare genetic disorder caused by a deficient or dysfunctional C1-INH protein. It is inherited in an autosomal dominant manner. Symptoms of HAE include episodes of edema, or swelling, in the hands, the feet, the face, the abdomen, and/or the larynx. Patients who have abdominal attacks of HAE can experience episodes of extreme pain, diarrhea, nausea and vomiting caused by swelling of the intestinal wall. HAE attacks that involve the face or throat can result in upper airway closure, asphyxiation and, if untreated, death. Diagnosis of HAE requires a blood test to confirm low or abnormal levels of C1-INH.
About CSL Behring
CSL Behring is a global biotherapeutics leader driven by its promise to save lives. Focused on serving patients’ needs by using the latest technologies, we develop and deliver innovative therapies that are used to treat coagulation disorders, primary immune deficiencies, hereditary angioedema, respiratory disease, and neurological disorders. The company’s products are also used in cardiac surgery, organ transplantation, burn treatment and to prevent hemolytic disease of the newborn.
CSL Behring operates one of the world’s largest plasma collection networks, CSL Plasma. The parent company, CSL Limited (ASX:CSL), headquartered in Melbourne, Australia, employs more than 27,000 people, and delivers its life-saving therapies to people in more than 100 countries. For more information visit www.cslbehring.com and follow us on www.Twitter.com/CSLBehring.
References:
- HAEGARDA® Product Monograph. CSL Behring Canada, Inc. August 13, 2019
- Longhurst H, Cicardi M, Craig T, et al. Prevention of Hereditary Angioedema Attacks with a Subcutaneous C1 Inhibitor. N Engl J Med. 2017;376(12):1131-1140.
- Bork K, et al. Clinical studies of sudden upper airway obstruction in patients with hereditary angioedema due to C1 esterase inhibitor deficiency. Ach Intern Med. 2003;163:1229-35.
- Bork K, et al. Efficacy of different medical therapies for the treatment of acute laryngeal attacks of hereditary angioedema due to C1-esterase inhibitor deficiency. J Emerg Med. 2016;50(4):567-80.
- Bork K, et al. Fatal laryngeal attacks and mortality in hereditary angioedema due to C1-INH deficiency. J Allergy Clin Immunol. 2012 Sep;130(3):692-7
CONTACT:
Media Contact: Natalie de Vane, Mobile: +1 610 999 8756, Email: [email protected]