The European Commission has granted Baxter International Inc. marketing authorization in all European Union (EU) Member States for the use of HyQvia (solution for subcutaneous use) as replacement therapy for adult patients with primary and secondary immunodeficiencies.

"HyQvia offers patients with primary and secondary immunodeficiencies the ability to administer their treatment in a single subcutaneous site every three to four weeks. This represents an important advance for patients who are managing a chronic disease as HyQvia combines  key benefits of intravenous and subcutaneous administration into one product," said Ludwig Hantson, Ph.D., president of Baxter's BioScience business. "We look forward to introducing HyQvia in the coming weeks to support physicians and adult immunodeficient patients in Europe."

Baxter will introduce HyQvia in select countries during 2013 and plans to expand the launch to other EU countries in 2014.

"We are delighted that these patients who depend on immunoglobulin replacement treatment will have access to HyQvia," said Gregory I Frost, Ph.D., president and chief executive officer, Halozyme Therapeutics.

The product is a combination of human normal immunoglobulin (IGSC, 10 per cent) and recombinant human hyaluronidase, which facilitates the dispersion and absorption of the IGSC. The application was based on results from a phase III, prospective, open-label, non-controlled multi-centre clinical trial, which evaluated the safety and effectiveness of HyQvia in the prevention of acute serious bacterial infections, and the pharmacokinetic parameters compared to immunoglobulin administered intravenously. The objective of the study was to infuse a three or four week dose of the treatment in a single subcutaneous site.

The rate of validated acute serious bacterial infections in the study was 0.025 per patient per year, which is below the required efficacy threshold of 1.0 (serious bacterial infections per patient per year). In the tolerability assessment of HyQvia, the most frequently reported adverse reactions were infusion site reactions (20 per cent of infusions), headache (three per cent of infusions), fatigue (one per cent of infusions) and pyrexia (fever) (one per cent of infusions).

HyQvia is a product consisting of human normal immunoglobulin (IGSC, 10%) and recombinant human hyaluronidase (licensed from Halozyme Therapeutics). The two components are packaged together as a dual vial unit: IGSC provides the therapeutic effect and the recombinant human hyaluronidase facilitates the dispersion and absorption of the IGSC, increasing the bioavailability. The IGSC is a 10 per cent solution that is prepared from human plasma consisting of at least 98 per cetn IgG, which contains a broad spectrum of antibodies.

Primary Immunodeficiencies (PI) are a group of more than 175 disorders in which part of the body's immune system is missing or does not function properly. Normally, the immune system protects the body from pathogenic microorganisms like bacteria, viruses, and fungi, which can cause infectious diseases. When any part of a person's immune system is absent or dysfunctional, they are more likely to become infected and may take longer to recover from infections. When a defect in the immune system is inherited, it is called primary, or inherited, immune deficiency. It is estimated that as many as six million children and adults are affected by PI worldwide.

Secondary immunodeficiencies develop as a result of a variety of conditions such as malignancies, particularly those of the haematopoietic and lymphoreticular systems, metabolic disease and/or malnutrition. Furthermore, burns or severe infection can also cause defective immune function and poor antibody response. In particular, immunoglobulin therapies are used to treat hypogammaglobulinaemia associated with chronic lymphocytic leukaemia (CLL) and multiple myeloma (MM). These patients may benefit from immunoglobulin replacement treatment in addition to standard treatment of their primary disease.

Baxter International Inc., through its subsidiaries, develops, manufactures and markets products that save and sustain the lives of people with haemophilia, immune disorders, cancer, infectious diseases, kidney disease, trauma and other chronic and acute medical conditions.

Halozyme Therapeutics, a partner of Baxter is a biopharmaceutical company dedicated to developing and commercializing innovative products that advance patient care.