FDA approves CSL Behring's sBLA to extend shelf life of Hizentra from 18 to 24 months

CSL Behring announced today that the U.S. Food and Drug Administration (FDA) has approved a supplemental Biologics License Application (sBLA) to extend the shelf life of Hizentra^®, Immune Globulin Subcutaneous (Human), 20% Liquid, from 18 months to 24 months. Hizentra, the first and only 20 percent subcutaneous immunoglobulin (SCIg) approved in the U.S. by the FDA, is also the first and only SCIg in the U.S. that may be stored at room temperature.

“CSL Behring continually enhances the products in our broad portfolio based on what we know patients and their healthcare providers need and want”

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 up to 24 months. Because no refrigeration is necessary, Hizentra is always ready to use without warming, offering patients and physicians convenience and portability.

"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."

The sBLA for Hizentra was based on a study assessing the product's stability. Physicochemical, biological and immunological parameters were assessed over 24 months' storage under controlled conditions at 25°C (77°F). The data generated from this study support that when Hizentra is stored at room temperature (up to 25ºC [77ºF]) and protected from light, it is stable for up to 24 months.

Hizentra with 24-month shelf life packaging is expected to be available later this year. Current Hizentra patients are encouraged to contact their physician with any questions regarding the shelf life of their current supply.

Hizentra is part of the immunoglobulin (Ig) franchise for CSL Behring. 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.

Source CSL Behring