CSL
Behring announced today that the U.S. Food and Drug Administration
(FDA) has granted marketing approval for HizentraTM, Immune
Globulin Subcutaneous (Human), 20% Liquid, for treating patients
diagnosed with primary immunodeficiency (PI). A once weekly
immunoglobulin (Ig) replacement therapy, Hizentra
provides effective protection against infection by maintaining a steady
and normal level of immunoglobulin in the body. Primary
immunodeficiencies constitute a group of disorders, usually genetic,
that cause a malfunction in all or part of the immune system, thereby
rendering the patient unable to fight off infections caused by everyday
germs.
“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.”
Hizentra is the first 20 percent subcutaneous immunoglobulin
(SCIg) approved in the U.S. by the FDA. This high-concentration product
is stabilized with L-proline, a naturally-occurring amino acid.
L-proline allows Hizentra to be stored at room temperature (up to
25°C [77°F]). Because no refrigeration is necessary, Hizentra is
ready to use, offering patients and physicians convenience and
portability. Hizentra can be safely self-administered by PI
patients under a physician's care.
"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,” said Robert
Lefebvre, Vice President and General Manager, U.S. Commercial
Operations at CSL Behring. “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.”
"With its high concentration, Hizentra is a welcome new SCIg
treatment option for patients managing primary immunodeficiencies,” said
John Sleasman, M.D., Professor and Chief of the Division of Allergy,
Immunology and Rheumatology at the University of South Florida College
of Medicine, Department of Pediatrics, and one of the investigators on
CSL Behring's clinical study of Hizentra. "Hizentra’s
ready-to-use attribute will allow patients to infuse the product where
and when it suits them, and physicians now have another product to
select to best meet the individual needs of their patients.”