Plasma-derived medicines company Grifols (MCE:GRF) (MCE:GRF.P) (NASDAQ: GRFS) reported on Thursday the receipt of US Food and Drug Administration (FDA) approval for the new Xembify 20% subcutaneous immunoglobulin for the treatment of primary immunodeficiencies.

The Spanish company said that Xembify (immune globulin subcutaneous, human- klhw) is a 20% immune globulin solution for subcutaneous injection indicated for treatment of Primary Humoral Immunodeficiency (PI) in patients aged two years and older. This includes, but is not limited to, congenital agammaglobulinemia, common variable immunodeficiency, X-linked agammaglobulinemia, Wiskott-Aldrich syndrome, and severe combined immunodeficiencies.‎

Following the FDA approval, the company plans to introduce Xembify in the US in the last quarter of 2019 and is working with healthcare authorities to obtain approval in Canada, Europe and other markets.

Immunoglobulins are mainly used to treat primary and secondary immunodeficiencies, as well as chronic inflammatory demyelinating polyneuropathy (CIDP).