Low-volume 1500 IU Vial Will Allow Patients a More Convenient Product Administration
OTTAWA, May 15, 2015 /CNW/ -- CSL Behring announced today that Health Canada has approved a new, low-volume presentation size for the existing indications of Berinert®, a human plasma-derived, pasteurized and nanofiltered C1-esterase inhibitor (C1-INH) concentrate. The new Berinert® 1500 IU format is reconstituted with 3 mL vial of Sterile Water for Injection (Diluent). In Canada, Berinert® is indicated for the treatment of acute abdominal, facial, or laryngeal attacks of hereditary angioedema (HAE) of moderate to severe intensity. Berinert®, licensed since 2010, is the first C1-INH available in Canada.
"Hereditary angioedema is a rare and serious disease that often requires intravenous treatment with C1- esterase inhibitor concentrate," said Paul Keith, M.D., Associate Professor, Division of Clinical Immunology and Allergy, Department of Medicine, McMaster University. "It can be life-threatening if not treated as soon as possible after the onset of an attack, which can often last 3 days.
"The new vial size with 1500 International Units of C1-esterase inhibitor can be prepared and administered faster than the same dose using the existing vial size of 500 IU. This is particularly significant for patients who weigh more than 50 kilograms. In the past, these patients had to mix three different vials of C1-esterase inhibitor before administration. This new concentrated formulation, the first of its kind for treating hereditary angioedema in Canada, allows patients over 50 kilograms to mix and administer just one vial."
The new Berinert® 1500 IU vial size will be launched in Canada shortly. "It is part of our commitment to the HAE Community to continuously bring innovative improvements and provide more treatment options to patients in Canada," said Philippe Hebert, General Manager of CSL Behring Canada. The existing vial size and formulation (Berinert® 500 IU reconstituted with 10 mL Sterile Water for Injection) will also continue to be available.
"This is very exciting news for Canadian HAE patients. Having this option available will improve convenience for those who currently use Berinert®. The ease of administration will help patients treat their attacks quicker at the first sign of symptoms," said Jacquie Badiou, President of HAE Canada, a patient advocate group whose vision is optimum health and well-being for those living with HAE and other related angioedema in Canada. HAE Canada's national office is located in Ottawa, Ontario.
About Hereditary Angioedema
HAE is a rare genetic disorder caused by a deficiency of C1-INH. 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.
Berinert® is a highly purified, human, C1-INH concentrate that rapidly treats the fundamental cause of hereditary HAE symptoms by providing C1-INH deficient patients with the missing human protein. Berinert® has been available for the treatment of HAE for over 30 years internationally, and has been used for more than half a million treatments.
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/.
1 An HAE attack of moderate intensity is characterized by a degree of discomfort caused by clinical HAE symptoms that results 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.
Christopher Florentz, CSL Behring, 610-878-4316
SOURCE CSL Behring