FDA Approves Xembify®, 20% Subcutaneous Immunoglobulin

Grifols has announced 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.

"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," said Joel Abelson, President of Commercial Bioscience Division.

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.

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