125683 Apr 2026

: 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.

: 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 . 125683

As of April 2026, here is an informative review of the clinical and regulatory findings associated with this product, specifically focusing on the data submitted under regarding infusion rate increases. Clinical Review of Xembify (STN: 125683) : While the Statistical Review noted some limitations

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