Grifols, a global leader in the production of plasma-derived medicines, has announced positive results from a Phase 4 study investigating the use of XEMBIFY®, its subcutaneous immunoglobulin product, administered every two weeks. The study successfully met its primary objective by demonstrating comparable levels of total immunoglobulins when compared to weekly administration in patients with primary immunodeficiencies. These findings indicate that biweekly dosing could be a viable option for patients and may lead to an expansion of XEMBIFY®'s approved usage, providing increased flexibility and convenience. Grifols is dedicated to addressing immunodeficiency disorders and aims to enhance its portfolio of leading immunoglobulin therapies.
The recently concluded Phase 4 trial (NCT04566692) evaluated the efficacy of XEMBIFY® when administered every two weeks and demonstrated non-inferiority in terms of total immunoglobulin levels compared to weekly administration in patients with primary immunodeficiencies. Additionally, the trial revealed similar safety and tolerability profiles between the two dosing regimens.