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July 31, 2014
14:00 EDTHALO, BAXBaxter, Halozyme announce favorable FDA panel recommendation on HyQvia
Baxter International (BAX) and Halozyme Therapeutics (HALO) announced that the Blood Products Advisory Committee of the FDA voted 15-1 that HyQvia, Baxter’s investigational subcutaneous treatment for patients with primary immunodeficiency, has a favorable risk/benefit profile. ''We are hopeful that the positive support for HyQvia is the next step toward providing a new treatment option for patients with primary immunodeficiency in the United States. We look forward to working closely with the FDA as it completes its review,'' said Ludwig Hantson, Ph.D., president of Baxter BioScience. HyQvia was approved in Europe in 2013 for adults with primary immunodeficiency syndromes and myeloma or chronic lymphocytic leukaemia with severe secondary hypogammaglobulinaemia and recurrent infections. HyQvia is a product consisting of human normal immunoglobulin and recombinant human hyaluronidase, licensed from Halozyme.
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