Baxter applies for EU approval of HyQ

Baxter has submitted an application for European regulatory approval of HyQ, its new therapy for primary immunodeficiencies.

The company has filed a submission with the European Medicines Agency's Committee for Human Medicinal Products for approval of subcutaneously-administered HyQ alongside recombinant human hyaluronidase.

Baxter is supporting this application with data from a phase III clinical study that showed the safety and efficacy of the drug in preventing acute serious bacterial infections.

It has already submitted a similar application to the US Food and Drug Administration earlier this year, while further clinical data on HyQ will be presented during a conference in November.

Ludwig Hantson, president of Baxter's bioscience business, said: "These efforts reinforce our ongoing commitment to innovation in delivering new therapy options for patients with these difficult-to-manage conditions."

Last month, the company provided sponsorship for a US summit on the topic of parenteral nutrition safety, which was hosted by the American Society for Parenteral and Enteral Nutrition.