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news.Baxter BioScience has submitted a marketing authorization application (MAA) to 17 competent authorities in Europe following the decentralized procedure (DCP) for approval of its investigational 20% concentration subcutaneous immune globulin (IGSC) treatment for primary immunodeficiencies (PI).
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Primary immunodeficiencies are a group of disorders in which part of the body’s immune system is missing or does not function properly.
The company is advancing the 20% treatment as part of its efforts to expand the primary immunodeficiency treatment portfolio to address patient needs.
Baxter BioScience vice-president and global head of research and development John Orloff said: "The data we’ve collected on our investigational 20% treatment support its potential role as a valuable alternative to other conventional IGSC products for patients with immunodeficiency disorders and have formed the basis of our regulatory submission in Europe.
"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.
"We are confident that this product will support these efforts and enhance the value of our immunology portfolio to the PI community."
The MAA is based on the positive results of a Phase II/III trial that evaluated the efficacy, safety, tolerability and pharmacokinetics (PK) of IGSC 20% in European patients at least two years old with PI.
The trial met its primary endpoint that measured the rate of validated acute serious bacterial infections (VASBIs).
Results from a separate trial of IGSC 20% among patients with PI in North America are expected to be available in the coming months; based on the outcome of this trial, the company intends to file for US approval of the treatment before the end of this year.