utaneous 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% of infusions), headache (3% of infusions), fatigue (1% of infusions) and pyrexia (fever) (1% 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.
"Recognizing 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 , Ph.D., 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% solution that is prepared from human plasma consisting of at least 98% 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.
Important Safety Information
HyQvia should not be used by women who are pregnant, or are planning to become pregnant, or are breast-feeding.
About Immunodeficiency Disorders
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