The first drug that could stop Alzheimer’s disease has to go through a fast-track process for approval, which experts say could be the biggest breakthrough yet.
Charities have said that U.S. watchdogs’ decision to give the treatment a “priority review” could see it prescribed within six months, giving hope to people with the disease around the world.
Trials have shown that patients who received the drug Aducanumab saw improvements in their language skills and ability to keep track of time and place, as well as slower memory loss.
Currently, drugs prescribed to treat Alzheimer’s disease can only mask the symptoms, rather than slow the development of the disease.
However, the new treatment, which works by helping unravel the plaque build-up in the brain, could be the first to stop the progression of the disease, trials suggest.
Experts said the drug could be targeted at people with early signs of dementia, which means the disease could be stopped or slowed down before people with the disease become unable to do so.
Alzheimer’s disease is the most common form of dementia in the UK, with around 500,000 people.
Samantha Benham-Hermetz, Director of Policy and Public Affairs at Alzheimer’s Research UK, said: “People affected by Alzheimer’s disease have long waited for life-changing treatment and today’s announcement gives hope that such treatment could be in sight. ”
She said: “It is reassuring that this devastating disease remains a priority concern for drug regulators and that no drug modifying Alzheimer’s disease reaches this far, and we are in uncharted territory.
The review will take six months to determine whether the drug is safe and effective, paving the way for its first license in the US, before being reviewed by watchdogs around the world, including those in the UK.
The drug has been closely watched by scientists after a roller coaster of test results.
Hopes that the drug would be the long-awaited breakthrough in dementia research were dashed last year when manufacturers Biogen and Eisai halted two late-stage trials and abandoned plans to develop the treatment.
Studies last fall had suggested that the treatment was not benefiting patients.
But five months later, Biogen said a new analysis with a larger amount of data, which became available after the trials stopped, found the drugs worked – as long as they were given early enough and at a dose. high.
The company is currently planning a new study, which will provide such doses to all eligible participants in previous trials.
The drug is the first application in 17 years to be reviewed by the FDA for the treatment of Alzheimer’s disease.
If successful, it would be the first treatment designed to delay the progression of Alzheimer’s disease to be approved by regulators.
The FDA only accepts drugs as part of their priority review process if they could offer major breakthroughs in treatments or provide treatments where none exist.
This means that a decision on the safety and effectiveness of drugs will be made within six months, instead of the standard 10 months allotted.
The companies said that the FDA “said that, if possible, it plans to act quickly on this application.” “
Shares of the drug’s maker, Biogen, rose 9% after the FDA announcement.
Aducanumab is a drug antibody designed to unravel the clumps of beta amyloid, 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 patients with Alzheimer’s disease.
Michel Vounatsos, CEO of Biogen, said: “We believe that Aducanumab marks the beginning of a new era of potential treatments for Alzheimer’s disease.”
Dr Haruo Naito, managing director of Eisai, said approval of the drug would be a “historic milestone”.
“Reducing clinical decline and maintaining the ability to live independent lives for as long as possible are things people with Alzheimer’s disease and their families value in potential treatment,” he said.
“If Aducanumab is approved, we expect it to make a difference in the lives of people with Alzheimer’s disease.”