FDA approves expanded indication for Hizentra in PI-CSL Behring

The FDA has expanded the administration options for Hizentra (human normal immunoglobulin 20% liquid), from CSL Behring, to include the ability to individualize therapy with flexible dosing – treatment at regular intervals from daily to once every two weeks (biweekly) – for people with primary immunodeficiency (PI).

Self-administered subcutaneously, Hizentra delivers consistent levels of immunoglobulin G (IgG) regardless of dosing schedule. FDA approval of flexible dosing for Hizentra is based on pharmacometrics (modeling and simulation). Clinical trials using these alternative Hizentra dosing regimens were not conducted.

Comment: PI is a group of serious diseases that compromise the immune system, leaving patients particularly vulnerable to infection. Approximately 250,000 Americans (or one person per 1,200) have been diagnosed with PI. Hizentra, the first and only 20 percent subcutaneous immunoglobulin, received FDA approval in March 2010 as a once-weekly IgG replacement therapy to help protect people with PI against infections and was approved for biweekly (once every two weeks) dosing in September 2013.