CSL Behring has received approval from the US Food and Drug Administration (FDA) for a new 10g (50mL) vial size of Hizentra, an immune globulin subcutaneous (human) liquid drug.
Hizentra, which is claimed to the first and only 20% subcutaneous immunoglobulin therapy, is indicated as replacement therapy in patients over 2 years old with primary immunodeficiency.
The liquid drug maintains serum immunoglobulin G (IgG) levels consistent week to week to protect people with primary immunodeficiency (PI) against infections.
About 250,000 individuals in the US are diagnosed with PI, which is a group of rare and serious diseases of the immune system.
The new vial size of the drug, which will be available in the US in October 2013, will reduce the number of vials that patients must use when higher doses are required.
CSL Behring senior vice president of North America Commercial Operations Lynne Powell said, "The availability of Hizentra in a 10 g vial will reduce vial preparation for infusion, therefore saving time for both patients and their caregivers."
Apart from the new 10g (50mL) vial, Hizentra is also available in 1g (5mL), 2g (10mL) and 4g (20mL) vials.