Grifols announces FDA approval of Xembify^®, 20% subcutaneous immunoglobulin for primary immunodeficiencies

Barcelona, July 4, 2019.- Grifols (MCE:GRF, MCE:GRF.P NASDAQ:GRFS), a leading global producer of plasma-derived medicines, announced today 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%¹ 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 CIDP².

Committed to long-term growth: R+D+i and capital investments

FDA approval of Xembify^® reflects Grifols’ steadfast commitment to R+D+i and innovation, which have enabled the company to continue developing new formulations and indications that enhance its portfolio of products.

Recent highlights include the 2018 FDA approval of a new intramuscular immunoglobulin (GamaSTAN^®) that provides immediate protection against hepatitis A and measles, and a new anti-rabies immunoglobulin (HyperRAB^®) to treat patients exposed to the rabies virus.

Grifols intends to allocate EUR 1,400 million toward capital investments over the 2018-2022 period in order to meet the growing demand for plasma-derived medicines and reinforce its long-term growth plan.

Especially noteworthy is the current construction of the world’s first purification and sterile filling plant of immunoglobulins in flexible packaging, located on Grifols’ industrial complex in Clayton (North Carolina, USA). The plant will require a EUR 140 million investment and is expected to be operational by 2022.

About Xembify^®

Indications and usage

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 2 years of age and older. This includes, but is not limited to, congenital agammaglobulinemia, common variable immunodeficiency, X-linked agammaglobulinemia, Wiskott-Aldrich syndrome, and severe combined immunodeficiencies.‎

Important Safety Information

• Thrombosis may occur with immune globulin products, including XEMBIFY^®. Risk factors may include: advanced age, prolonged immobilization, hypercoagulable conditions, history of venous or arterial thrombosis, use of estrogens, indwelling vascular catheters, hyperviscosity, and cardiovascular risk factors. Thrombosis may occur in the absence of known risk factors. 
• For patients at risk of thrombosis, administer XEMBIFY^® at the minimum dose and infusion rate practicable. Ensure adequate hydration in patients before administration. Monitor for signs and symptoms of thrombosis and assess blood viscosity in patients at risk for hyperviscosity.

Warnings and precautions

• Hypersensitivity and anaphylactic reactions may occur. IgA deficient patients with antibodies against IgA are at greater risk of developing severe hypersensitivity or anaphylactic reactions.
• Aseptic Meningitis Syndrome (AMS) may occur within two days of treatment.
• Monitor for renal function in patients at risk for renal failure.
• Hemolysis can develop. Risk factors include high doses and non-O blood group. Closely monitor for hemolysis and hemolytic anemia.
• Monitor patients for pulmonary adverse reactions (transfusion-related acute lung injury [TRALI]).
• XEMBIFY^® is made from human plasma and may carry a risk of transmitting infectious agents, e.g., viruses, the variant Creutzfeldt-Jakob disease (vCJD) agent and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent.
• Passive transfer of antibodies may confound serologic testing.

Contraindications

• Anaphylactic or severe systemic reactions to human immunoglobulin or inactive ingredients of XEMBIFY^® such as polysorbate 80.
• IgA deficient patients with antibodies against IgA and a history of hypersensitivity

Adverse reactions

The most common adverse reactions in ≥ 5% of subjects in the clinical trial were local adverse reactions including infusion site erythema (redness), infusion site pain, infusion site swelling (puffiness), infusion site bruising, infusion site nodule, infusion site pruritus (itching), infusion site induration (firmness), infusion site scab, infusion site edema, and systemic reactions including cough and diarrhea.

To report SUSPECTED ADVERSE REACTIONS, contact Grifols Therapeutics at 1-800-520-2807 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

¹  Source: Grifols Global Plasma Database, Provisional Data 2018.
² Source: Data on File; US, Canada, Spain, Germany, France, Italy