CSL’s Hizentra SCIG Receives FDA Approval

CSL Behring has received Food and Drug Administration approval for its Hizentra immune globulin (IG) subcutaneous (human) 20% liquid for treating patients diagnosed with primary immunodeficiency (PI). The onceweekly IG replacement therapy is the first 20 percent subcutaneous IG (SCIG) approved in the U.S.

Hizentra is a high-concentration product stabilized with L-proline, a naturally-occurring amino acid. It can be stored at room temperature, requiring no refrigeration, making it ready to use by patients who can safely self-administer it. “As the first SCIG treatment with a 20 percent concentration of immunoglobulin, Hizentra represents an effective, convenient choice of at-home IG therapy that will allow people with PI to schedule treatment around their busy lives, instead of scheduling their lives around treatment,” says Robert Lefebvre, vice president and general manager, U.S. Commercial Operations at CSL Behring.