The FDA has approved a supplemental Biologics License Application (sBLA) to extend the shelf life of Hizentra (immune globulin subcutaneous [Human] 20% Liquid, from CSL Behring) from 18 to 24 months. Hizentra is stabilized with the amino acid L-proline and can be stored at room temperature. The sBLA for Hizentra was based on a study that assessed physicochemical, biological and immunological stability parameters over 24 months’ storage under controlled conditions at 25°C (77°F). The data supported 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.
Hizentra is indicated as replacement therapy for the treatment of primary immunodeficiency.
For more information call (800) 504-5434 or visit www.hizentra.com.