Baxter International Inc. and Halozyme Therapeutics, Inc., announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has granted a positive opinion to Baxter for the use of HyQvia (solution for subcutaneous use) as replacement therapy for adult patients with primary and secondary immunodeficiencies. 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.

"This recommendation supports our efforts to improve the overall quality of care for patients. This therapy, when approved by the European Commission, would offer patients the option to administer their therapy at home, in a single subcutaneous site every three to four weeks, resulting in potentially lower systemic adverse reactions compared to intravenous treatments," said Ludwig Hantson, PhD., president of Baxter's BioScience business. "We look forward to introducing HyQvia as a new patient-friendly therapeutic option for immunodeficient patients."

The application was based on results from a phase III, prospective, open-label, non-controlled design 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 therapy in a single subcutaneous site.

The acute serious bacterial infection rate 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). Upon receiving marketing authorization from the European Commission, Baxter plans to launch HyQvia in selected countries in the European Union later this year.

"Recognising that the path to approval for any biologic is a long journey, I would like to thank and congratulate the teams at Halozyme and Baxter who have worked tirelessly to advance this therapeutic option for patients", said Gregory I Frost, PhD., president and chief executive officer, Halozyme Therapeutics.

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 cent IgG, which contains a broad spectrum of antibodies.

HyQvia is indicated as replacement therapy in adults (>18 years) in primary immunodeficiency syndromes and in myeloma or chronic lymphocytic leukaemia with severe secondary hypogammaglobulinaemia and recurrent infections.

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 is a biopharmaceutical company dedicated to developing and commercializing innovative products that advance patient care.