First Alzheimer’s drug that can stop disease in its tracks nears approval
THE first drug that could halt Alzheimer’s could be offered to patients in Britain within a year, with watchdogs now considering whether to give the treatment the green light.
Trials have found that patients given aducanumab saw improvements in their language skills and ability to keep track of time and place, and a slower loss of memory.
Currently, drugs to help those with dementia can only mask symptoms, and it is almost two decades since these sorts of medicines have been approved.
Scientists hope that the new treatment, which works by helping to untangle clumps of plaque in the brain, could be the first to halt disease progression.
Earlier this year, US health watchdogs fast-tracked the treatment for priority review and yesterday t he European Medicines Agency announced it would review the drug.
The process is expected to take less than a year, with British watchdogs likely to follow its lead in deciding whether to licence the drug.
Alzheimer’s is the most common form of dementia in the UK, with around 500,000 sufferers. The treatment has been keenly watched by scientists after a rollercoaster of trial results. Hopes that the drug is the longawaited breakthrough in dementia research were dashed last year when manufacturers Biogen and Eisai halted two late-stage trials and scrapped plans to develop the treatment. The studies last autumn had suggested the treatment did not benefit patients.
But five months later, Biogen said a new analysis with a larger amount of data that became available after the trials stopped, found that the drugs did work – as long as they were given early enough, and at a high dosage.
Experts said the drug could be targeted at those with early signs of dementia, meaning that the disease could be halted or slowed before sufferers become incapacitated by it. Further studies are now under way, offering 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 to be approved by regulators.
Aducanumab is an antibody drug designed to untangle clumps of amyloid beta protein plaques that form in the brain – a hallmark of Alzheimer’s.
Scientists believe that these plaques are at least partially responsible for memory loss and cognitive decline.
Samantha Benham-hermetz, director of policy and public affairs at 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 20 years.
“However, it must make it through a number of steps before it is approved. With so many people desperate for a new treatment to work, we need to be sure that the regulators are satisfied that this drug is safe and clinically effective.”
Michel Vounatsos, chief executive officer at Biogen, said: “We believe aducanumab represents the first breakthrough that can change the course of this devastating disease.”