BERN, Switzerland, April 21, 2011 /PRNewswire/ -- CSL Behring announced today that the European Commission has granted marketing authorization for Hizentra(R) (Human Normal Immunoglobulin), 20 percent 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.

CSL Behring is a subsidiary of CSL Limited . Hizentra is currently marketed in the United States. It received U.S. 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, 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. As a leader in developing safe, high-quality, effective Ig therapies for use around the world, CSL Behring is proud to add this important addition to our expanding product portfolio."

This high-concentration product is stabilized with L-proline, a naturally occurring amino acid. L-proline allows Hizentra to be stored at room temperature (up to 25 degrees C [77 degrees F]). The European Commission has cleared Hizentra with an initial storage shelf life of two years. Because no refrigeration is necessary, Hizentra is ready to use, offering patients and physicians convenience and portability.

As the first 20 percent subcutaneous immunoglobulin (Ig), Hizentra provides lower infusion volumes, combined with consistent and steady levels of immunoglobulin resulting in effective protection against infection.

Hizentra is part of the CSL Behring immunoglobulin (Ig) franchise. This comprehensive Ig product portfolio also includes the first U.S. FDA-approved subcutaneous immunoglobulin and the first proline-stabilized intravenous immunoglobulin. CSL Behring manufactures Hizentra at its state-of-the-art facility in Bern, Switzerland, where advanced technologies are applied to further ensure product safety and ample supply. This facility represents the long-term commitment of CSL Behring to global Ig markets.

Study Design

The European Commission approval of Hizentra was based on results from a prospective, open-label, multicenter, single-arm, clinical study conducted in Europe, evaluating the efficacy, tolerability, and safety of Hizentra in adult and pediatric subjects with PI. In the study, 51 PI patients (3 to 60 years old), previously treated with IVIg or SCIg therapies, received weekly subcutaneous infusions of Hizentra at doses equivalent to those used in previous treatment. The primary endpoint to sustain IgG trough levels comparable to the previous treatment was achieved (mean trough level of 8.10 g/L for Hizentra). While the mean IgG trough level increased by 17.7 percent in patients who had been with IVIG (6.78 g/L pre-study level ), it remained similar in patients who had been previously treated with subcutaneous Ig (pre-study level of 8.43 g/L). No serious bacterial infections were reported during the efficacy period in patients receiving Hizentra during the clinical study. Almost all adverse events (98.7 percent) were mild to moderate in intensity.