Baxter International Inc. (BAX) and Halozyme Therapeutics Inc., (HALO) announced that the European Medicines Agency's Committee for Medicinal Products for Human Use or EMA 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%) and recombinant human hyaluronidase, which facilitates the dispersion and absorption of the IGSC.
Upon receiving marketing authorization from the European Commission, Baxter plans to launch HyQvia in selected countries in the European Union later this year.
The companies warned that HyQvia should not be used by women who are pregnant, or are planning to become pregnant, or are breast-feeding.
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