DEMENTIA/ALZHEIMER’S DISEASE

THE first new pharmaceutical drug for Alzheimer’s in almost two decades has won approval in the United States – raising hopes that the drug could soon be used in the UK.

Aducanumab targets the cause of the disease rather than its symptoms.

Medical and health charities have welcomed the announcement, describing its approval as a “major milestone” for the millions of people living with dementia. But scientists are divided because of the uncertainty over trial results.

The US Food and Drug Administration said there was “substantial evidence that aducanumab reduces amyloid beta plaques”. Amyloid is a protein that forms clumps in the brain that can damage cells and trigger dementia. Aducanumab works by sticking to these clumps and removing them.

However, late-stage international trials of the treatment in 2019, involving about 3,000 patients, were halted when analysis showed the drug was no better at slowing the deterioration of memory than a placebo. Following further analysis, manufacturer Biogen said the drug did work and significantly slowed cognitive decline if given in higher doses.

Biogen have not released the cost of the treatment, but analysts estimate it could cost up to £35,000 a year. Tens of thousands of Britons with a mild form of the disease could be suitable for the drug if it were to be approved here.

Professor Bart De Strooper, director the UK Dementia Research Institute, said: “With no effective therapies currently available to modify the progression of this devastating condition, this is a major milestone for the millions of people living with Alzheimer’s. However, I fear the controversy and uncertainty surrounding the trials will limit the impact of this new treatment for the disease.”

A spokesperson for the research department at the Alzheimer’s Society, said: “It’s promising to see that aducanumab has been approved for use in people with early-stage Alzheimer’s disease – the first drug to be approved in nearly 20 years by the US regulatory authorities.

“We await the opinion of the European Medicines Agency and the outcome of any application made to the UK regulatory authorities, to give clarity to people with early Alzheimer’s disease in the UK. Whatever the outcome of their decision, this is just the beginning of the road to new treatments for Alzheimer’s disease.”

Another health charity, Alzheimer’s Research UK, said it had written to UK Health Secretary Matt Hancock asking the Government to prioritise the fast-track approval process for the drug in the UK.

Its chief executive, Hilary Evans, said: “People with dementia and their families have been waiting far too long for life-changing new treatments.”