Expanded approval for Grifols’ Xembify in USA

Spanish drugmaker Grifols (MCE: GRF), one of the world’s leading producers of plasma-derived medicines, has announced that the US 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.

FDA approval of the Supplemental Biologics Application (sBLA) also includes biweekly dosing and is supported by Phase IV trial data shared last year.