CSL Behring said the new PK model allows the absorption, distribution, metabolism, and elimination of SC IgG following administration to be simulated with a high degree of accuracy and precision.
The new model provides a novel means of simulating the mechanism by which SC IgG is transported after it is injected into the subcutaneous tissue.
After SC injection into the extra vascular space, the model describes the interplay between IgG being broken down before reaching the circulation and also salvaged from this space to be returned to the bloodstream.
The fate of IgG is similar between IVIG and SC IgG after it reaches the intravascular compartment.
CSL Behring Global Clinical Research and Development program director Martin Bexon said the model increases knowledge of how SC IgG is distributed throughout the body and has the potential to help further optimize a dosing schedule that balances the convenience and therapeutic value of Hizentra for primary immunodeficiency (PI) patients.
Hizentra (Immune Globulin Subcutaneous [Human]) is part of the immunoglobulin (Ig) franchise for CSL Behring.
Approved in the US and in registration in the EU and Switzerland, Hizentra is indicated for the treatment of patients with PI and contraindicated in individuals with a history of anaphylactic or severe systemic response to immune globulin preparations or components of Hizentra, and in persons with selective immunoglobulin A deficiency who have known antibody against IgA and a history of hypersensitivity.