FDA Advisory Committee Recommends Baxter’s Immunodeficiency DrugBy
An advisory committee of the US Food and Drug Administration (FDA) has recommended for approval an immunodeficiency drug developed by Baxter International Inc. and Halozyme Therapeutics, Inc. The FDA’s Blood Products Advisory Committee (BPAC) voted 15-1 that HyQvia (immune globulin infusion 10% (human) with recombinant human hyaluronidase), Baxter’ subcutaneous treatment for patients with primary immunodeficiency has a favorable risk/benefit profile.
The FDA will consider the recommendation from the BPAC in its review of Baxter’s amendment to the biologics license application submitted in December 2013. The company expects the FDA response in the third quarter.
HyQvia was approved by the European Commission for EU member states in 2013 and is currently being prescribed in several European countries, including Germany, the Netherlands, Sweden, Norway, Denmark, Ireland, and Italy. HyQvia was approved in Europe in 2013 for adults (â‰¥18 years) with primary immunodeficiency syndromes and myeloma or chronic lymphocytic leukemia with severe secondary hypogammaglobulinaemia and recurrent infections.
â€‹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 to increase its bioavailability.