Drug that could halt Alzheimer's may be available to UK patients within a year
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, along with a slower loss of memory.
Currently, drugs to help those with dementia can only mask symptoms, and it is almost two decades since even these sorts of medicines have been given the go-ahead.
Scientists hope 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 years, US health watchdogs fast-tracked the treatment for priority review, and now the European Medicines Agency has announced that it will review the drug for use in Europe.
The process is expected to take less than a year, with British watchdogs likely to follow their lead in deciding whether to licence the drug.
Alzheimer's disease is the most common form of dementia in the UK, affecting for around 500,000 people.
The treatment has been keenly watched by scientists after a rollercoaster of 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.
Studies last autumn had suggested the treatment did not benefit patients. However, 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 the disease could 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 the 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 these plaques are at least partially responsible for memory loss and cognitive decline in Alzheimer's patients.
Samantha Benham-Hermetz, the 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.
"The 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, 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 regulators are satisfied that this drug is safe and clinically effective."
Michel Vounatsos, the chief executive officer at Biogen, the manufacturer 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."
