NEW DRUG COULD HALT ALZHEIMER’S PROGRESSION

Possibly available within six months

The first drug that could halt Alzheimer’s is to be fasttracked for approval, in what experts say could be the biggest breakthrough yet.

Charities said the decision by U.S. watchdogs to give the treatment a “priority review” could mean it would be prescribed within six months, giving hope to sufferers everywhere. Trials have found that patients given aducanumab showed improvements in their language skills and ability to keep track of time and place, and a slower loss of memory.

Currently, medicines prescribed for Alzheimer’s can only mask the symptoms. But the new treatment, which works by helping to untangle clumps of plaque in the brain, could be the first to halt disease progression, trials suggested.

Experts said the drug could target those with early signs of dementia, meaning it could be halted or slowed before they became incapacitated.

Samantha Benham-Hermetz, director of policy and public affairs at Alzheimer’s Research UK, said: “People affected by Alzheimer’s have waited a long time for a lifechanging treatment and today’s announcement offers hope that one could be in sight.”

She added: “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, we are in uncharted territory.”

The review will take six months to establish if the drug is safe and effective, paving the way for it to be licensed first in the U.S., before being considered by other medical watchdogs around the world. The drug’s efficacy has been keenly watched by scientists after a roller-coaster 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.

The studies last autumn had suggested that the treatment would not be of benefit to sufferers.

But five months later, Biogen said a new analysis, with a larger amount of data that had become available after the trials stopped, found that the drugs did work — as long as they were given early enough, and with a sufficiently high dosage. The company is now planning further studies, 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 U.S. Food and Drug Administration 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 Food and Drug Administration only accepts drugs under its priority review process if they could offer major advances in treatments or provide treatment where none had previously existed.

It means that a decision on the safety and effectiveness of the drug will be taken within six months, rather than the standard 10 months normally allocated.

The companies said the FDA had stated that “if possible, it plans to act early on this application.”

Shares for the drug’s maker, Biogen, rose nine per cent after the FDA made the announcement.

Aducanumab is an antibody drug that 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 that these plaques are at least partially responsible for memory loss and cognitive decline in Alzheimer’s patients.

Michel Vounatsos, chief executive at Biogen, a multinational biotech firm in Cambridge, Mass., said: “We believe that aducanumab marks the beginning of a new era of potential treatments for Alzheimer’s disease.”

And Haruo Naito, chief executive at Eisai, a pharmaceutical firm based in Japan, 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 and their families value in a potential treatment,” he said.

“If aducanumab is approved, we expect it will make a difference in the lives of people living with Alzheimer’s.”