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GEN News Highlights : Mar 5, 2010

FDA Sanctions CSL Behring’s Subcutaneous Immunoglobulin Therapy

High-concentration formulation is indicated to treat patients with primary immunodeficiency.

CSL Behring obtained FDA approval for Hizentra™, a once-weekly immunoglobulin (Ig) replacement therapy. The decision is a first for a 20% subcutaneous (SC) formulation, according to the firm.

This high-concentration product is stabilized with L-proline, a naturally occurring amino acid. L-proline allows Hizentra to be stored at room temperature. Hizentra will be manufactured at CSL Behring’s new facility, located at its center of excellence for immunoglobulins in Bern, Switzerland.

The FDA approval of Hizentra was based on results from a prospective, open-label, multicenter, single-arm, clinical study conducted in the U.S. in adult and pediatric subjects with primary immunodeficiency (PI). In this study, subjects previously receiving IVIg treatments every three or four weeks were switched to weekly subcutaneous administration of Hizentra for 15 months.

“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, vp and GM, U.S. commercial operations at CSL Behring.

CSL Behring reports that it provides more than a dozen Igs to treat immune deficiencies. This includes Vivaglobin, a subcutaneous Ig treatment, and a proline-stabilized IVIg therapy.