Grifols receives expanded XEMBIFY® (immune globulin subcutaneous human-klhw) label in U.S., strengthening its Ig portfolio for patients

Core Insights - Grifols has received FDA approval for an expanded label for XEMBIFY, the first and only 20% subcutaneous immunoglobulin (SCIg) that allows treatment-naïve patients to start therapy without prior intravenous treatment [1][2][3] - The approval includes biweekly dosing, which has shown comparable total Ig levels to weekly dosing in a phase 4 clinical trial [3][4] - The adoption of XEMBIFY aligns with Grifols' broader strategy in the immunoglobulin market, which is expected to grow significantly due to increasing cases of primary and secondary immunodeficiencies [5][6] Company Strategy - The expanded label for XEMBIFY enhances patient convenience and flexibility, differentiating it from other SCIg therapies [6] - Grifols plans to launch the new label in the U.S. in Q3 2024, reflecting its commitment to adapting to patient needs [6] - The global immunoglobulin market is projected to grow in the high single digits, with immunodeficiencies accounting for up to 55% of the total market [5] Clinical Data - The phase 4 clinical trial (NCT04566692) included 27 subjects across 18 U.S. sites and demonstrated non-inferiority in total Ig levels for biweekly dosing compared to weekly dosing [3][4] - No unique safety issues were identified in the trial, and the tolerability profiles were consistent between dosing schedules [4] Product Information - XEMBIFY is a 20% solution of purified human immunoglobulin, primarily immune globulin G (IgG), made from large pools of human plasma [8][9] - It is indicated for primary humoral immunodeficiency (PI) in patients aged 2 years and older in the U.S., and for both PI and select secondary immunodeficiencies in Europe, Canada, and Australia [7]