August 14, 2024 – We are delighted to share that Grifols announced that the United States Food and Drug Administration (FDA) has approved an expanded label for XEMBIFY®, the company’s 20% subcutaneous immunoglobulin (SCIg), to include treatment-naïve patients with primary humoral immunodeficiencies (PI). XEMBIFY becomes the first 20% SCIg with this extended label, allowing patients to begin SCIg therapy without first having intravenous 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, Grifols Chief Scientific Innovation Officer.
The Jeffrey Modell Foundation is proud to partner with Grifols in support of the Primary Immunodeficiency community, and we are pleased to witness this new development for patient treatment and care.
Read the full press release here.