Grifols XEMBIFY receives European approvals

pharmafile | March 15, 2022 | News story | Manufacturing and Production  

Grifols has announced that XEMBIFY, its innovative 20% subcutaneous immunoglobulin (SCIG), has been approved by several European Union member state health authorities, along with the UK’s.

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

Including PIDD patients in Europe, it is estimates that approximately 27,000 are candidates for IG therapy, with SCIG increasingly being used over the intravenous option.

Immunoglobulins are mainly used to treat primary and secondary immunodeficiencies, as well as rare neurological conditions, such as chronic inflammator demyelinating polyneuropathy (CIDP).

XEMBIFY features a balanced formulation for treating a wide range of patients with immunodeficiencies, including those with risk factors such as diabetes or cardiac impairment. It has maximum immunoglobulin G (IgG) potency and purity, due to its unique caprylate/chromatography process, and provides a customisable IG treatment option which allows patients to have 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,” commented 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.”

Lina Adams

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