Baxter re submits HyQvia at FDA for Immunodeficiency
Baxter International Inc. and Halozyme Therapeutics, Inc. announced that Baxter has completed submission of an amended biologics license application (BLA) to the FDA to re-initiate the review process for approval of HyQvia [Immune Globulin Infusion 10% (human) with Recombinant Human Hyaluronidase] facilitated subcutaneous infusion for the treatment of adult patients with Primary Immunodeficiency (PI).
HyQvia is a combination of human immune globulin (IG) and recombinant human hyaluronidase. Baxter and Halozyme submitted additional preclinical data that was requested from the FDA in 2012, and expect a six-month review period.
HyQvia was approved and launched in a number of European countries in the second half of 2013.
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