CSL Behring announced today that the FDA has approved a
supplemental Biologics License Application (sBLA) to extend the shelf life of
Hizentra(R), Immune Globulin Subcutaneous (Human), 20% Liquid, from 24 months
to 30 months. Hizentra, the first and only 20 percent subcutaneous
immunoglobulin (SCIg) approved in the U.S.,
is the only SCIg in the U.S.
that can be stored at room temperature throughout its entire shelf life.
Hizentra is indicated for the treatment of primary humoral immunodeficiency
(PI). PI is a group of disorders, usually genetic, that result from a
dysfunctional immune system. This condition prevents patients from fighting off
infections caused by common germs.
“Based on what we know patients and their healthcare
providers need and want, CSL Behring continually strives to enhance the
products in our extensive portfolio,” said Lynne Powell, CSL Behring
Senior Vice President, North America
Commercial Operations. “The ability to store Hizentra without
refrigeration for up to two and a half years is a milestone that provides added
convenience to busy and active patients, while serving as another example of
CSL Behring’s dedication to meeting customer needs.” Stabilized with
L-proline, a naturally occurring amino acid, Hizentra can be stored at room
temperature (up to 25 C 77 F) for up to 30 months. Because no refrigeration is
necessary, Hizentra is always ready to use without warming, offering patients
and physicians convenience and portability.
“Since transitioning to Hizentra, I havethe freedom to
choose the time of day and in what setting I self-infuse my therapy,” said
Hizentra patient Jean Stefanic. “The convenience this product offers fits
my busy schedule and helps me lead a normal life.” The sBLA for Hizentra
was based on a study assessing the product’s stability for 30 months.
Physicochemical, biological and immunological parameters were assessed under
controlled conditions at 25 C (77 F).
The data generated from this study demonstrated that when
Hizentra is stored at room temperature (up to 25C 77F) and protected from light,
it is stable for up to 30 months.
Hizentra with 30-month shelf life packaging is expected to
be available later this year. Current Hizentra patients are encouraged to contact
their physician with any questions regarding the shelf life of their current
supply.
