Baxter receives EU approval for Advate product summary update

Baxter has announced that the European Medicines Agency has approved a product labelling update for Advate, its therapy for haemophilia A patients.

The company is amending the Summary of Product Characteristics (SmPC) for Advate to include findings from its recent phase IV prophylaxis study, in order to help inform treatment decisions.

In the trial, Baxter compared standard and pharmacokinetic-guided (PK-guided) prophylaxis dosing regimens to on-demand treatment with Advate, demonstrating that both methods are equally effective, but the latter option can allow some patients to receive fewer infusions per year.

Dr Anders Ullman, vice-president of global research and development for Baxter's bioscience business, said: "This addition to our Advate SmPC offers clinicians and patients in Europe information about pharmacokinetics that may enable them to better personalise their treatment regimens."

This comes after the company recently reported positive data from a study that demonstrated the benefits Advate can offer to haemophilia patients in both clinical and real-world settings.