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news.Health Canada has granted approval for CSL Behring's new, low-volume presentation size for the existing indications of Berinert, a human plasma-derived, pasteurized and nanofiltered C1-esterase inhibitor (C1-INH) concentrate, for the treatment of hereditary angioedema.
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The company said that the new Berinert 1500 IU format is reconstituted with 3mL vial of Sterile Water for Injection (Diluent).
In Canada, Berinert is indicated to treat acute abdominal, facial, or laryngeal attacks of hereditary angioedema (HAE) of moderate to severe intensity.
McMaster University Division of Clinical Immunology and Allergy, Department of Medicine associate professor Paul Keith said: "Hereditary angioedema is a rare and serious disease that often requires intravenous treatment with C1- esterase inhibitor concentrate.
"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 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."
According to the company, the new Berinert 1500 IU vial size will be launched in Canada shortly.
The existing vial size and formulation Berinert 500 IU reconstituted with 10mL Sterile Water for Injection will also continue to be available.