Grifols Announces FDA Approval of Xembify, 20% Subcutaneous Immunoglobulin for Primary Immunodeficiencies

Grifols announced that Xembify, its new 20% subcutaneous immunoglobulin, has been approved by the U.S. Food and Drug Administration (FDA). Xembify is used to treat primary immunodeficiencies.

The FDA approval marks the culmination of an important R+D+i initiative for Grifols, as well as an opportunity to enhance the Bioscience Division’s product portfolio. Grifols is currently a market leader in the production and marketing of immunoglobulins, with 30.3% market share (grams) in the United States. Thus, this approval reinforces Grifols’ commitment to patients in the United States, allocating an increasing part of its production to supply the needs of this market.

According to Joel Abelson, President of Commercial Bioscience Division, “This approval reinforces Grifols’ longstanding commitment to patients and healthcare professionals by expanding our product portfolio to better serve individuals with primary immunodeficiencies. We are pleased to offer patients living with this challenging chronic disease another important treatment option.”

The company plans to launch Xembify in the United States 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 rare neurological conditions, such as chronic inflammatory demyelinating polyneuropathy (CIDP). Immunoglobulin use continues to grow in major markets. From 2015-2017, immunoglobulin volumes have experience annual growth rates of about 10% for primary and secondary immunodeficiencies and CIDP.