Hizentra is said to be the first and only immune globulin treatment for primary immunodeficiency and chronic inflammatory demyelinating polyneuropathy
CSL Behring receives FDA nod for Hizentra 50mL prefilled syringe. (Credit: CSL Limited)
Biotechnology company CSL Behring has received approval from the US Food and Drug Administration (FDA) for its 50mL/10gm prefilled syringe for Hizentra (Immune Globulin Subcutaneous [Human] 20% Liquid).
Hizentra is said to be the first and only immune globulin (Ig) treatment for primary immunodeficiency (PI) or chronic inflammatory demyelinating polyneuropathy (CIDP).
With the latest approval, CSL Behring now has a full line of prefilled syringe sizes to offer to meet the individual needs of people living with PI or CIDP.
The 50mL prefilled syringe is expected to be available in early 2024.
Additionally, Hizentra will continue to be offered in 5mL, 10mL, and 20mL prefilled syringes and in 5mL, 10mL, 20mL, and 50mL vials as well.
The biotechnology company claimed that the syringe is the most prescribed self-infused subcutaneous immune globulin (SCIg) treatment for PI in the US and the first and only SCIg treatment approved for CIDP.
CSL Behring SVP and North America general manager Bob Lojewski said: “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.
“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.”
Hizentra was first approved by the US health regulator in March 2010 for the treatment of PI. About eight years later, it was cleared for the treatment of adults with CIDP to prevent relapse of neuromuscular disability and impairment.
In November last year, CSL Behring secured FDA approval for Hemgenix (etranacogene dezaparvovec-drlb) for the treatment of adults with haemophilia B.