Alzheimer's disease treatment set to be fast-tracked in medical breakthrough

Laura Donnelly
·4 min read
Patients given the drug Aducanumab saw improvements in language skills and a slower loss of memory - Huy Mach/ Washington University
Patients given the drug Aducanumab saw improvements in language skills and a slower loss of memory - Huy Mach/ Washington University

The first drug which could halt Alzheimer's disease is to be fast-tracked for approval in what experts say could be the biggest breakthrough yet.

Charities said the decision by US watchdogs to give the treatment a "priority review" could see it prescribed within six months, giving hope to sufferers around the world.

Trials have found that patients given the drug Aducanumab saw improvements in their language skills and ability to keep track of time and place, along with a slower loss of memory.

Currently, medicines prescribed to treat Alzheimer's disease can only mask the symptoms rather than slow the development of disease. 

However, the new treatment, which works by helping untangle clumps of plaque in the brain, could be the first to halt the disease's progression, trials suggest.

Experts said the drug could be targeted at those with early signs of dementia, meaning the disease could could be halted or slowed before sufferers become incapacitated by it. 

Alzheimer's disease is the most common form of dementia in the UK, affecting around 500,000 people.

Samantha Benham-Hermetz, the director of policy and public affairs at Alzheimer's Research UK, said: "People affected by Alzheimer's disease have waited a long time for a life-changing treatment, and today's announcement offers hope that one could be in sight.

"It is reassuring that this devastating disease remains a priority concern for drug regulators and, with no disease-modifying Alzheimer's drugs getting this far before, and we are in uncharted territory."

The review will take six months to establish whether the drug is safe and effective, paving the way for it to be licensed first in the US before being considered by watchdogs around the world, including those in the UK.

The drug has been keenly watched by scientists after rollercoaster trial results. 

Hopes that the drug is the long-awaited 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 the drugs did work as long as they were given early enough and at a high dosage.

The company is now planning a new study which will offer such doses to all eligible participants from the earlier trials. 

The drug is the first application in 17 years to be reviewed by the FDA for treatment of Alzheimer's disease. 

If successful, it would be the first treatment designed to delay progression of Alzheimer's disease to be approved by regulators. 

The FDA only accepts drugs under its priority review process if they could offer major advances in treatments or provide treatment where none existed. It means a decision on the safety and effectiveness of the drugs will be taken within six months rather than the standard 10 months allocated. 

The companies said the FDA "has stated that, if possible, it plans to act early on this application". Shares in Biogen rose nine per cent after the FDA announcement. 

Aducanumab, an antibody drug, is designed to untangle clumps of amyloid beta, protein plaques that form in the brain and are a hallmark of Alzheimer's. Scientists believe these plaques are at least partially responsible for memory loss and cognitive decline in Alzheimer's patients.  

Michel Vounatsos, the chief executive officer at Biogen, said: "We believe that Aducanumab marks the beginning of a new era of potential treatments for Alzheimer's disease."

Dr Haruo Naito, the chief executive at Eisai, said approval of the drug would be a "historic milestone".

"Reducing clinical decline and maintaining the ability to live an independent life for as long as possible are things that people living with Alzheimer’s disease and their families value in a potential treatment," he said. 

"If Aducanumab is approved, we expect that it will make a difference in the lives of people living with Alzheimer's disease."