FDA approval for Hizentra (20% liquid) 50mL//10gm prefilled syringe to treat primary immunodeficiency and chronic inflammatory demyelinating polyneuropathy

CSL Behring now offers a full range of prefilled syringe sizes to meet the individual needs of people living with Primary Immunodeficiency (PI) or Chronic Inflammatory Demyelinating Polyneuropathy (CIDP). Hizentra is the first and only immune globulin (Ig) available in a simple, convenient and ready-to-use prefilled syringe.

Hizentra is the most prescribed self-infused subcutaneous immune globulin (SCIg) treatment for PI in the U.S. and the first and only SCIg treatment approved for CIDP. The 50mL prefilled syringe will be available in early 2024, which will allow CSL Behring to manufacture supply to meet anticipated demand. Hizentra will continue to be available in 5mL, 10mL and 20mL prefilled syringes as well as in 5mL, 10mL, 20mL, and 50mL vials.

"As part of our promise to meet the needs of people who rely on our life-saving therapies, we recognize the important value of offering people with PI or CIDP a larger prefilled syringe size option to effectively manage their condition," said Bob Lojewski, Senior Vice President and General Manager, North America, CSL Behring. "We are proud to be at the forefront of delivering effective treatment options that also provide flexibility by allowing those with PI or CIDP to self-administer their treatments based on their specific needs and lifestyles."