Berinert (R) Approved by Health Canada for the Treatment of Hereditary Angioedema (HAE) in Pediatric Patients
OTTAWA, Canada, Aug. 9, 2017 /CNW/ -- CSL Behring is pleased to announce that on March 31st, 2017 Berinert (C1 Esterase Inhibitor, Human) was approved by Heath Canada for Pediatric Hereditary Angioedema (HAE).
"HAE is an unpredictable and life threatening disease with few treatment options approved for children," said Paul Keith, M.D., Associate Professor, Division of Clinical Immunology and Allergy, Department of Medicine, McMaster University. "Berinert's new indication for use in the pediatric population provides a much needed treatment option for this vulnerable patient group."
"The HAE Canada Team is so excited that CSL Behring listened to patients, caregivers, family members. This approval for Berinert in pediatric patients is a very important achievement for our children and parents living with HAE in Canada," said Jacquie Badiou, President of HAE Canada, a patient advocate group whose mission is to create awareness about HAE and to enable patients to become champions of their own quality of life. HAE Canada's national office is located in Ottawa, Ontario.
Berinert is indicated for the treatment of acute abdominal, facial, or laryngeal attacks of hereditary angioedema of moderate to severe intensity* in pediatric and adult patients.The safety and efficacy of Berinert for prophylactic therapy has not been established.1
About Berinert
Berinert 500/Berinert 1500 (reduced volume), commonly referred to as Berinert, is a purified, pasteurised, nanofiltered, lyophilised concentrate of human C1 esterase inhibitor (C1-INH) to be reconstituted for intravenous administration. It is prepared from large pools of human plasma. Administration of Berinert during a swelling episode or prior to surgery has been shown to alleviate or prevent the swelling by increasing the levels of functional C1-INH in the body1.Berinert was first introduced in Canada on June 01, 2010.
Berinert is contraindicated in individuals who have a known hypersensitivity or have had an anaphylactic or severe systemic reaction to C1-INH preparations or to any ingredient in the formulation or component of the container. 1
Products made from human plasma may contain infectious agents such as viruses and, theoretically, the agent responsible for the Creutzfeldt-Jakob disease (CJD).1
CSL Behring recommends the use of its products only as indicated. For more information and complete risk/benefit profile, please contact Customer Service at 1-866-773-7721 ext.2386 or refer to the Product Monograph available on our website at http://labeling.cslbehring.ca/PM/CA/Berinert/EN/Berinert-Product-Monograph.pdf.
About CSL Behring
CSL Behring is a leader in the plasma protein therapeutics industry. Committed to saving lives and improving the quality of life for people with rare and serious diseases, the company manufactures and markets a range of plasma-derived and recombinant therapies worldwide.
CSL Behring therapies are used around the world to treat coagulation disorders including hemophilia and von Willebrand disease, primary immune deficiencies, hereditary angioedema and inherited respiratory disease, and neurological disorders in certain markets. The company's products are also used in cardiac surgery, organ transplantation, burn treatment and to prevent hemolytic diseases in the newborn.
CSL Behring operates one of the world's largest plasma collection networks, CSL Plasma. CSL Behring is a global biopharmaceutical company and a member of the CSL Group of companies. The parent company, CSL Limited (ASX:CSL), is headquartered in Melbourne, Australia. For more information, visit http://www.cslbehring.com/.
Reference
1 Berinert (R) 500 / Berinert (R)1500 Product Monograph. CSL Behring Canada; March 31, 2017.
*An HAE attack of moderate intensity is characterized by a degree of discomfort caused by clinical HAE symptoms that result in some interference with daily activities. An HAE attack of severe intensity is characterized by a degree of discomfort caused by clinical HAE symptoms that makes it impossible to perform daily activities.
SOURCECSL Behring
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