Grifols Achieves Positive Topline Results From Phase 4 Study of XEMBIFY® (immune globulin subcutaneous human-klhw) Evaluating Biweekly Dosing Option for Patients
It has demonstrated that patients with primary immunodeficiencies (PIDs) treated with this subcutaneous 20% immunoglobulin (SCIg) product every two weeks achieved non-inferiority in total Ig levels compared with those who received the medication weekly.
- It has demonstrated that patients with primary immunodeficiencies (PIDs) treated with this subcutaneous 20% immunoglobulin (SCIg) product every two weeks achieved non-inferiority in total Ig levels compared with those who received the medication weekly.
- The phase 4 trial also demonstrated similarly good safety and tolerability profiles between biweekly and weekly administration.
- Results will support the potential product labeling extension of XEMBIFY® to include biweekly dosing, pending review and approval by the United States Food and Drug Administration.
- “Patients using XEMBIFY® could have an additional dosing option to choose from, providing more convenience and flexibility when controlling their immunodeficiencies,” said Kim Hanna, Grifols Senior Director Clinical Development.