CSL Behring received approval from the FDA for its sBLA to extend the shelf life of Hizentra, Immune Globulin Subcutaneous (Human), 20% Liquid, from 18 months to 24 months. Hizentra is the only 20% subcutaneous immunoglobulin (SCIg) approved in the U.S. It’s also the first SCIg in the U.S. that can be stored at room temperature.
Hizentra is indicated for the treatment of primary immunodeficiency (PI). PI is a group of disorders, usually genetic, that result from a dysfunctional immune system. This condition prevents patients from fighting off infections caused by common germs. Stabilized with L-proline, a naturally occurring amino acid, Hizentra can be stored at room temperature (up to 25°C / 77°F) for as long as 24 months and is always ready to use without warming.
“CSL Behring continually enhances the products in our broad portfolio based on what we know patients and their healthcare providers need and want,” said Robert Lefebvre, vice president and general manager, U.S. Commercial Operations at CSL Behring. “The ability to store Hizentra without refrigeration for up to two years is an innovation that can positively impact busy and active patients managing their primary immunodeficiency at home or in any setting that is convenient for them.”
FDA Approves Hizentra Shelf Life Extension
Published August 19, 2010
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