Baxter International Inc. (NYSE:BAX) and Halozyme Therapeutics, Inc., (NASDAQ:HALO) today announced that the Blood Products Advisory Committee (BPAC) of the U.S. Food and Drug Administration (FDA) voted 15-1 that HyQvia [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase], Baxter’s investigational subcutaneous treatment for patients with primary immunodeficiency (PI), has a favorable risk/benefit profile.
HyQvia was approved in Europe in 2013 for adults (≥18 years) with primary immunodeficiency syndromes and myeloma or chronic lymphocytic leukaemia (CLL) with severe secondary hypogammaglobulinaemia and recurrent infections.
Data presented at today’s advisory committee meeting included a review of the preclinical and clinical data supporting the HyQvia application. The FDA will consider the recommendation from the BPAC in its review of Baxter’s amendment to the Biologics License Application (BLA) submitted in December 2013. The company expects the FDA response in the third quarter.
''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.
''Today’s BPAC vote underscores the strength of the HyQvia data and our rHuPH20 platform,'' commented Dr. Helen Torley, President and Chief Executive Officer of Halozyme. ''Our rHuPH20 platform has been studied in thousands of patients spanning multiple disease states and a number of approved products.''
HyQvia was approved by the European Commission for EU member states in 2013 and is currently being prescribed in several European countries, including Germany, Netherlands, Sweden, Norway, Denmark, Ireland and Italy.
HyQvia is a product consisting of human normal immunoglobulin (IG 10%) and recombinant human hyaluronidase (licensed from Halozyme Therapeutics). The IG provides the therapeutic effect and the recombinant human hyaluronidase facilitates the dispersion and absorption of the IG administered subcutaneously, increasing its bioavailability. The IG is a 10% solution that is prepared from human plasma consisting of at least 98% IgG, which contains a broad spectrum of antibodies.