Xembify Receives Expanded Label for PI Patients
- By BSTQ Staff
The U.S. Food and Drug Administration has approved an expanded label for Grifols’ XEMBIFY (20% subcutaneous immune globulin [SCIG]) to include treatment-naïve patients with primary humoral immunodeficiencies (PI). Approval makes XEMBIFY the first 20% SCIG with this extended label, allowing patients to begin SCIG therapy without first having intravenous administration. Approval of the supplemental biologics application also includes biweekly dosing.
Approval is based on data from a Phase IV multicenter, single-sequence, open-label clinical trial that included 27 subjects across 18 U.S. sites, which met its primary endpoint, demonstrating that patients with PI treated with XEMBIFY every two weeks achieved non-inferiority in total IG levels compared with those who received the medication every seven days. There were no unique safety issues identified in the trial, and the tolerability profiles were consistent between biweekly and weekly administration.
“The XEMBIFY label expansion eliminates the need for patients to have initial intravenous treatment, which differentiates XEMBIFY from other SCIG therapies, plus offers patients greater convenience and flexibility with biweekly dosing,” said Joerg Schuettrumpf, chief scientific innovation oficer at Grifols. “Grifols plans to launch the new label in the U.S. in the third quarter of 2024 as part of the company’s commitment to increasing options for patients and adapting to their needs and lifestyles.”
