Potential Alzheimer’s treatment to be reviewed ‘within a year’ for use in EU
30 October 2020
Today (Friday 30 October 2020) the European Medicines Agency (EMA) accepted Biogen’s application to review a potential Alzheimer’s drug, aducanumab for use in the EU.
The drug will need to be approved by regulators before it could be offered more widely to the general population.
What is aducanumab?
Aducanumab is an antibody designed to target amyloid, a protein that builds up in the brains of people with Alzheimer’s at an early stage in the disease process.
The pharmaceutical company, Biogen originally halted Phase III clinical trials of aducanumab, called ENGAGE and EMERGE in May 2019, when early indications suggested they would not benefit people in the early stages of Alzheimer’s disease.
However, following a new analysis with a larger amount of data that became available after the trials stopped, in August, Biogen filed for market approval with American drug regulator, the FDA. The FDA have accepted the proposal under their priority review process and is expected to make a decision by March 2021.
What is happening now?
Now the EMA have accepted an application to review the drug for use in people with Alzheimer’s disease in the EU.
Biogen is also planning a new study to re-offer the drug to eligible participants from their earlier trials of aducanumab.
Our expert’s view
Samantha Benham-Hermetz, Director of Policy and Public Affairs from 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. Today’s 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.
“Alzheimer’s Research UK will continue to work with regulators and drug developers to help speed up access to promising new treatments for those that need them.