FDA expands Hizentra administration options for people with primary immunodeficiency

CSL BehringSep 28 2013

CSL Behring announced today that the U.S. Food and Drug Administration (FDA) has expanded the administration options for Hizentra^®, Immune Globulin Subcutaneous (Human), 20% Liquid, to include dosing once every two weeks (biweekly) for people diagnosed with primary immunodeficiency (PI). Hizentra, the first and only 20 percent subcutaneous immunoglobulin, received FDA approval in March 2010 as a once weekly immunoglobulin G (IgG) replacement therapy. Self-administered weekly or biweekly, Hizentra delivers consistent levels of IgG to help protect those with PI against infections.

PI is a group of serious diseases of the immune system. Approximately 250,000 individuals (or one person per 1,200) in the U.S. are diagnosed with PI. Biweekly (every two weeks) dosing with Hizentra offers patients the same level of protection as weekly infusions, while providing users with the option of infusing less frequently. Moreover, because Hizentra can be stored at room temperature, it's ready to use.

"To provide the best care to PI patients, therapy needs to be individualized to meet particular needs. Fortunately, today we have options on treatment administration, dose and dosing interval," said Richard L. Wasserman, M.D., Ph.D., Clinical Professor of Pediatrics, University of Texas Southwestern Medical School. "With the approval of biweekly dosing, Hizentra provides PI patients with an additional option to be in greater control of their lives."

FDA approval of biweekly (every two weeks) dosing for Hizentra is based on the principles of pharmacometrics and pharmacokinetic modeling.

"CSL Behring has long been at the forefront of developing Ig replacement therapy advances that provide healthcare professionals with the ability to individualize treatments to meet their patients' lifestyle needs and preferences," said Lynne Powell, Senior Vice President, North America Commercial Operations, CSL Behring. "We are extremely pleased to now offer PI patients the option of dosing Hizentra weekly or biweekly. This new dosing option underscores CSL Behring's commitment to meeting the individual needs of patients who rely on our lifesaving therapies."