Xembify receives expanded label for treatment-naïve primary humoral immunodeficiencies patients

Xembify receives expanded label for treatment-naïve primary humoral immunodeficiencies patients | Image Credit: © Calin - © Calin - stock.adobe.com.

The FDA has approved an expanded label for Xembify (immune globulin subcutaneous human-klhw; Grifols) to include include treatment-naïve patients with primary humoral immunodeficiencies (PI).¹

With the decision from the federal agency, the company's 20% subcutaneous immunoglobulin (SCIg) becomes the first to include the extended label, which will allow patients to begin SCIg therapy without first having intravenous administration, according to a press release from Grifols.¹

Support for the extended label is from the a phase 4 clinical trial (NCT04566692). In the study, Xembify met the primary endpoint demonstrating that patients with PI treated with Xembify every 2 weeks achieved non-inferiority in total lg levels compared to those who received the medication every 7 days.^1,2

"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 Officer, Grifols, in a statement.¹

"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,” added Schuettrumpf.¹

Xembify is made from large pools of human plasma via modifications of the Immune Globulin (Human), 10% Caprylate/Chromatography Purified (IGIV-C 10%) manufacturing process. The current indication for subcutaneous injection is for treatment of PI in patients 2 years and older, and is for subcutaneous administration only.¹

References:

1. Grifols receives expanded Xembify (immune globulin subcutaneous human-klhw) label in U.S., strengthening its Ig portfolio for patients. Grifols. Press release. July 29, 2024. Accessed July 29, 2024. https://www.grifols.com/en/view-news/-/news/grifols-receives-expanded-xembify-immune-globulin-subcutaneous-human-klhw-label-in-us-strengthening-its-ig-portfolio-for-patients
2. A Study to Evaluate IGSC 20% Biweekly Dosing in Treatment-Experienced Participants and Loading/​Maintenance Dosing in Treatment-Naïve Participants With Primary Immunodeficiency. ClinicalTrials.gov. Updated September 29, 2024. Accessed July 29, 2024. https://www.clinicaltrials.gov/study/NCT04566692?cond=Primary%20Immunodeficiency&term=Grifols&intr=subcutaneous%20immunoglobulin&rank=4