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: While the Statistical Review noted some limitations due to small sample sizes in higher-rate groups, they concluded there were no major statistical issues that would prevent the labeling changes.

: 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

The reference corresponds to the Biologics License Application (BLA) for Xembify (Immune Globulin Subcutaneous [Human], 20%), a subcutaneous immunoglobulin (SCIG) therapy manufactured by Grifols . 125683

High concentration (20%) allows for lower infusion volumes and faster delivery. Generally well-tolerated at rates up to 35 mL/hour/site. Primary Risks

: Recent studies (e.g., Study GTI1503) demonstrated that Xembify is well-tolerated at higher infusion rates of $\geq$35 mL/hour/site , compared to the previously approved maximum of 25 mL/hour/site . : While the Statistical Review noted some limitations

: 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.

Xembify is indicated for the treatment of in patients aged 2 years and older. Recent clinical reviews by the FDA have focused on Supplemental Biologics License Applications (sBLA) to increase the maximum allowable infusion rates. Efficacy and Tolerability Generally well-tolerated at rates up to 35 mL/hour/site

: The most common adverse events identified in reviews are Infusion Site Reactions (ISRs) , such as pain, swelling, and redness. Clinical data indicated that increasing the infusion rate did not result in a material difference in the pattern or severity of these reactions compared to slower rates. Regulatory Perspective