Further studies are now underway, which offer such doses to all eligible participants from the earlier trials. If successful, it would be the first treatment designed to delay progression of Alzheimer’s disease to be approved by regulators.
Aducanumab is an antibody drug which is designed to untangle clumps of amyloid beta, protein plaques that form in the brain, and are a hallmark of Alzheimer’s disease.
Scientists believe that these plaques are at least partially responsible for memory loss and cognitive decline in Alzheimer’s patients.
Samantha Benham-Hermetz, director of policy and public affairs, Alzheimer’s Research UK, said: “Following Biogen’s decision to apply for licensed approval of aducanumab for use in Alzheimer’s disease in the US, they have now followed it up with an application to the European Medicines Agency.
“The news is that this agency has accepted it for review, potentially bringing EU patients closer to the first new dementia drug in nearly twenty years.
“However, aducanumab must make it through a number of steps before it is approved. With so many people desperate for a new Alzheimer’s treatment to work, we need to be sure that the regulators are satisfied that this drug is safe and clinically effective,” she said.
Michel Vounatsos, chief executive officer at Biogen, manufacturers of the drug, said: “Alzheimer’s disease has become a significant and growing burden for societies around the world, and we believe aducanumab represents the first breakthrough that can change the course of this devastating disease.
“We are committed to working with regulatory authorities worldwide and we look forward to the European Medicines Agency’s review of this application.”