Baxter Seeks European Approval for IG Therapy
Baxter International has submitted an application to the EMA seeking marketing authorisation for the company's investigational immunoglobulin therapy.
US-based health care company Baxter International has submitted an application to the European Medicines Agency's Committee for Human Medicinal Products seeking marketing authorisation for HyQ, the company's investigational immunoglobulin (IG) therapy for use in patients with primary immunodeficiencies (PI).
The submission 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, as well as the pharmacokinetic parameters of HyQ compared to IG administered intravenously.
The aim of the study was to infuse HyQ at a three or four week IG dose in a single site, and it found that the acute serious bacterial infection rate was 0.02
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