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news.FDA has granted marketing approval to CSL Behring for Hizentra, Immune Globulin Subcutaneous (Human), 20% Liquid, for treating patients diagnosed with primary immunodeficiency (PI).
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Hizentra, a once weekly immunoglobulin (Ig) replacement therapy, provides effective protection against infection by maintaining a steady and normal level of immunoglobulin in the body.
CSL Behring claimed that Hizentra is the first 20% subcutaneous immunoglobulin (SCIg) approved in the US by the FDA. This high-concentration product is stabilized with L-proline, a naturally-occurring amino acid.
Reportedly, the FDA approval of Hizentra was based on results from a prospective, open-label, multicenter, single-arm, clinical study conducted in the US, evaluating the efficacy, tolerability and safety of Hizentra in adult and pediatric subjects with PI.
In the study, subjects previously receiving IVIg treatments every three or four weeks were switched to weekly subcutaneous administration of Hizentra for 15 months (a three-month wash-in/wash-out period followed by a 12-month efficacy period). The efficacy of Hizentra was analyzed in 38 subjects who received at least one infusion after the wash-in/wash-out period.
Robert Lefebvre, vice president and general manager of US commercial operations at CSL Behring, said: “As the first SCIg treatment with a 20% 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.
“Hizentra is an important new addition to the rapidly growing CSL Behring product portfolio, and further demonstrates our long-standing commitment to the PI and rare disease communities.”