March 10, 2022

Grifols’ XEMBIFY® receives European approvals, expanding access to innovative therapies

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  • The company plans to launch XEMBIFY®, its 20% subcutaneous immunoglobulin for primary and secondary immunodeficiencies, in France, Spain and the U.K. as soon as the third quarter of 2022
  • Grifols solidifies its IG leadership and further expands the innovative reach of its plasma-derived medicines to benefit patients
  • Already available in the U.S., XEMBIFY® has proven to be safe, efficacious and tolerable and is formulated for a broad range of patients with immunodeficiencies

Barcelona, Spain, March 10, 2022 - Grifols (MCE:GRF, MCE:GRF.P, NASDAQ:GRFS), a leading global producer of plasma-derived medicines, today announced that XEMBIFY® , its innovative 20% subcutaneous immunoglobulin (SCIG), has been approved by several European Union member state health authorities as well as the U.K.’s to treat primary and select secondary immunodeficiencies.

Rollout will begin as soon as the third quarter of 2022 in France, Spain and the U.K. before extending to other European markets. XEMBIFY® availability will provide access to another innovative Grifols IG treatment option where the company already can offer its intravenous IG therapies Gamunex® and Flebogamma®.

Approved indications in Europe for XEMBIFY® include primary immunodeficiencies (PIDD), covering chronic and rare genetic disorders that occur in people born with an impaired or absent immune system. They also cover select secondary immunodeficiencies (SID), when a body’s defenses are compromised by environmental factors such as illness or malnutrition.

Just including PIDD patients in Europe, it’s estimated that about 27,000 are candidates for IG therapy1, with SCIG  increasingly being used over the intravenous option.

XEMBIFY®, with proven safety, efficacy and tolerability, features a balanced formulation for treating a wide range of patients with immunodeficiencies, including those with risk factors such as diabetes or cardiac impairment2. With maximum immunoglobulin G (IgG) potency and purity due to its unique caprylate/chromatography process, XEMBIFY® provides a customizable IG treatment option (daily or weekly) that offers patients reliable protection from infections.

“Approval across Europe enables Grifols to expand its innovative European IG product portfolio and provide patients and healthcare professionals with another important treatment option for primary and secondary immunodeficiencies,” said Thierry Heinrich, Vice President of Sales & Commercial, Grifols Bioscience Division, Europe. “We are very pleased to take another step in our continuous work to enhance the lives and well-being of people living with chronic rare diseases.”

The company, a market leader in the production and marketing of immunoglobulins, launched XEMBIFY® in the U.S. in December 2019.

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.  Between 2016-2020, immunoglobulin volume was estimated to have had an average annual growth rate of more than 8%1.

 

1Source: MRB, Global Usage and Forecast of the Immunoglobulin Market by Region
2Source: Patel, S. Y., Carbone, J., & Jolles, S. (2019). The expanding field of secondary antibody deficiency: causes, diagnosis, and management. Front Immunol 8 (10): 33. https://doi.org/10.3389/fimmu.2019.00033