According to BioSpace, a marketing authorisation application for the investigational immunoglobulin (IG) therapy HyQ has been submitted to the European Medicines Agency’s Committee for Human Medicinal Products. The product, which is administered subcutaneously and facilitated by recombinant human hyaluronidase (a dispersion and permeation enhancer), is intended for use in patients with primary immunodeficiencies.

The submission is based on results from a prospective, uncontrolled phase III study, 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.  Please see the link below for further details.