FDA approves new vial size for CSL Behring immune treatment
KING OF PRUSSIA, Pa. — The Food and Drug Administration has approved a new vial size for a treatment for a rare immune system disorder.
CSL Behring announced the approval of a 10-g, or 50-mL, vial size for Hizentra (immune globulin subcutaneous [human]). The product is used to prevent infections in patients with primary immunodeficiency, and the new vial size will be available in October.
Diseases in the PI group affect about 250,000 people in the United States. The company said the new vial size would help reduce the number of vials patients must use when higher doses are required. Hizentra is already available in 1-g, 2-g and 4-g vials.
"CSL Behring remains dedicated to providing every patient with options that will enhance his or her treatment experience," CSL Behring SVP 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."