Baxter seeks European marketing authorization for HyQ to treat PI

Baxter International Inc. announced today that it has submitted an application to the European Medicines Agency's Committee for Human Medicinal Products seeking 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 (PI).

"We understand the challenges faced by patients with PI and know they are in need of new options that can reduce the burden of treating the disease," said Professor Hartmut Ehrlich, vice president, research and development, Baxter's BioScience business. "The trial we conducted found that the combination of our IG with this dispersion enhancing enzyme will facilitate subcutaneous administration and, if approved, may become an important new therapeutic option for this patient community."

The submission, which follows a similar application submitted to the United States Food and Drug Administration (FDA) earlier this year, 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.

The objective of the study was to infuse HyQ at a 3 or 4 week IG dose in a single site. The acute serious bacterial infection rate in the study was 0.025 per patient per year, which is below the required efficacy threshold of 1.0. In the tolerability assessment of HyQ, the most frequently reported adverse reactions were infusion site reactions (20% of infusions), headache (3% of infusions), fatigue (1% of infusions) and pyrexia (fever) (1% of infusions). Baxter will be presenting study results during the American College of Allergy, Asthma and Immunology (ACAAI) annual meeting in Boston in November.

"Along with our development progress in markets around the world, the submission of our European MAA for HyQ is another important milestone in our efforts to deliver valuable new options that will benefit physicians and their patients," said Ludwig Hantson, president, Baxter's BioScience business. "These efforts reinforce our ongoing commitment to innovation in delivering new therapy options for patients with these difficult to manage conditions."