Baxter files for EU approval of new immunodeficiency treatment

Baxter's BioScience business has applied for European regulatory approval of a new treatment for primary immunodeficiencies via the decentralised procedure.

The investigational 20 percent concentration subcutaneous immune globulin (IGSC) treatment has demonstrated its efficacy, safety, tolerability and pharmacokinetics in phase II/III clinical studies, showing its ability to reduce validated acute serious bacterial infections.

Primary immunodeficiencies refer to a group of disorders in which part of the body's immune system is missing or does not function properly. There is a need for new approved therapies in this area.

Baxter also intends to file for US approval of the treatment before the end of 2015.

John Orloff, vice-president and global head of research and development for Baxter BioScience, said: "As we build on our legacy of innovation in the interest of patients worldwide, we aim to identify and address priorities for our patient communities around the world."

The company is still in the process of spinning off its biopharmaceuticals division as a standalone company, which will operate under the name Baxalta once complete.