Germany-based CSL Behring says that the European Commission has granted marketing authorization for Hizentra (human normal immunoglobulin), 20% solution for subcutaneous injection, for treating patients diagnosed with primary immunodeficiency (PI) as well as secondary immunodeficiencies.
This authorization is valid for all 29 European/European Economic Area member states and comes after a positive recommendation from the European Medicines Agency’s advisory panel earlier this year (The Pharma Letter February 21). CSL Behring is a subsidiary of Australia’s CSL Limited (ASX: CSL). Hizentra is currently marketed in the USA, having received Food and Drug Administration approval in March 2010.
"Hizentra is an exciting new offering in Europe that represents an effective, convenient choice of at-home subcutaneous Ig therapy for people with primary and secondary immunodeficiencies," said Paul Perreault, executive vice president, worldwide commercial operations, at CSL Behring. "Because it is ready-to-use, Hizentra enables patients to infuse the product where and when it suits them, and physicians now have another product to select to best meet the individual needs of their patients,” he added.
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