125683 Apr 2026

The reference corresponds to the Biologics License Application (BLA) for Xembify (Immune Globulin Subcutaneous [Human], 20%), a subcutaneous immunoglobulin (SCIG) therapy manufactured by Grifols .

: Pharmacokinetic (PK) data supported the safety of these changes, confirming that the drug's effectiveness in maintaining protective IgG levels remains consistent even with faster administration. Summary of Benefits vs. Risks Clinical Observation Primary Indication Treatment of Primary Immunodeficiency (PI). Key Advantage 125683

: This increase allows for significantly shorter infusion times, which is a major factor in treatment adherence and quality of life for patients requiring long-term immune globulin replacement therapy. 125683