Core Insights - The FDA has approved an expanded label for XEMBIFY, allowing biweekly dosing for treatment-naïve patients with primary humoral immunodeficiencies (PI), marking it as the first 20% subcutaneous immunoglobulin (SCIg) to do so [15][2][4] Company Strategy - The increasing adoption of XEMBIFY aligns with Grifols' broader immunoglobulin (Ig) business strategy, which focuses on treating immunodeficiencies that account for over 55% of the total Ig market [3][4] - Grifols plans to launch the new label in the U.S. in Q3 2024, emphasizing its commitment to enhancing patient options and adapting to their needs [4][15] Market Outlook - The global Ig market is projected to grow in the high single digits in the coming years, driven by rising cases of primary immunodeficiencies (PI) and secondary immunodeficiencies (SID) [3][29] - Ig treatment for immunodeficiencies is expected to outpace other indications, indicating a favorable market environment for Grifols [3] Product Information - XEMBIFY is a 20% immune globulin solution for subcutaneous injection, indicated for patients aged 2 years and older with primary humoral immunodeficiency [5][18] - The product is designed to provide greater convenience and flexibility for patients, eliminating the need for initial intravenous treatment [4][15] Clinical Data - Phase 4 clinical trial data demonstrated that patients treated with XEMBIFY every two weeks achieved non-inferiority in total Ig levels compared to those receiving weekly doses [2][16] - The trial included 27 subjects across 18 U.S. sites, with no unique safety issues identified, indicating consistent tolerability profiles between biweekly and weekly administration [16]
Grifols receives expanded XEMBIFY® (immune globulin subcutaneous human-klhw) label in U.S., strengthening its Ig portfolio for patients