Baxter files subcutaneous HyQ at EMA for Primary Immune Deficiency

The European Medicines Agency's Committee for Human Medicinal Products (CHMP)has accepted an application from Baxter International for a marketing authorization for HyQ. HyQ is Baxter's investigational immunoglobulin (IG) therapy administered subcutaneously and facilitated by recombinant human hyaluronidase, a dispersion and permeation enhancer, for use in patients with primary immunodeficiencies. The application is based on results from a phase III, prospective, open-label, non-controlled design clinical trial, which evaluated the safety and effectiveness of HyQ in the prevention of acute serious bacterial infections, and the pharmacokinetic parameters of HyQ compared to IG administered intravenously.