Richard Wasserman, MD, PhD, Medical Director of Pediatric Allergy and Immunology at Medical City Children’s Hospital, discusses the FDA expanded label approval for Xembify (immune globulin subcutaneous human-klhw) for primary immunodeficiencies (PIDs).
PIDs are a group of rare, genetic diseases affecting the immune system. There are over 200 different types of PIDs. Impaired immune system function causes patients to be at risk of developing chronic infections.
The U.S. Food and Drug Administration has approved an expanded label for Xembify, a 20% subcutaneous immunoglobulin treatment, to include biweekly dosing and treatment-naïve patients. The treatment was originally approved in 2019 for patients with PIDs with a weekly dosing. The expansion allows patients to utilize the treatment without first trying intravenous therapy.
The expansion approval follows data from the phase 4, multicenter, single-sequence, open label study evaluating biweekly dosing of 20% subcutaneous immune globulin human-klhw in treatment-naïve patients with PIDs. The primary endpoint, demonstrating patients treated every two weeks were noninferior in total immune globulin levels to those treated weekly, was achieved. Additionally, no new safety effects were observed and tolerability remained consistent with that of weekly dosing.
The expansion of Xembify gives patients greater flexibility and convenience in their treatment and care.
To learn more about primary immunodeficiencies and other rare autoimmune disorders, visit https://checkrare.com/diseases/autoimmune-auto-inflammatory-disorders/
