Pharma Focus Europe

Grifols Announces Positive Topline Results From Phase 4 Study of XEMBIFY® (Immune Globulin Subcutaneous Human-klhw) Evaluating Biweekly Dosing Option for Patients

Friday, July 21, 2023

Grifols, a leading producer of plasma-derived medicines, has announced positive results from a phase 4 trial (NCT04566692) evaluating the use of XEMBIFY® in patients with primary immunodeficiencies (PIDs). The trial demonstrated that administering the subcutaneous 20% immunoglobulin (SCIg) product every two weeks was as effective as the weekly dosing, achieving non-inferiority in total Ig levels.

The study, conducted across 18 U.S. sites with 27 subjects, also found that the biweekly dosing of XEMBIFY® had a similar safety and tolerability profile compared to the weekly administration. Based on these promising results, Grifols aims to extend the product labeling of XEMBIFY® to include the biweekly dosing option in the United States, where it is already authorized in European markets, pending approval from the Food and Drug Administration.

Kim Hanna, Grifols Senior Director of Clinical Development, emphasized that the additional dosing option for XEMBIFY® could offer greater convenience and flexibility for patients managing their immunodeficiencies. Grifols is committed to expanding its portfolio of immunoglobulin therapeutics to meet the growing demand, given the increasing number of people living with immunodeficiencies.

XEMBIFY® has demonstrated both efficacy and tolerability and is currently approved for use in primary immunodeficiency diseases (PIDD) in the U.S., and primary and select secondary immunodeficiencies (SIDs) in Europe, Canada, and Australia. The global market for immunoglobulin (Ig) is expected to experience significant growth, primarily due to the rise in PIDs and SIDs, which together constitute up to 55% of the total Ig market. Notably, the prevalence of SIDs has increased due to factors such as an aging population and the use of immunosuppressive therapies, where Ig remains the preferred and only option.

XEMBIFY® is a 20% solution of purified human immunoglobulin, mainly composed of immune globulin G (IgG), derived from large pools of human plasma using modifications of the IGIV-C 10% manufacturing process. It is indicated for the treatment of primary humoral immunodeficiency disease (PIDD) in patients aged 2 years and older, with subcutaneous administration.

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