Alzheimer’s drug given US approval

By Published On: 7 June 2021
Alzheimer’s drug given US approval

The first new treatment for Alzheimer’s disease for nearly 20 years has been approved by regulators in the United States.

Aducanumab targets the underlying cause of Alzheimer’s, the most common form of dementia, rather than its symptoms.

An estimated 850,000 people live with dementia in the UK – around 100,000 of whom with early stage dementia could benefit from the drug – with the US approval of aducanumab giving hope that it could next be approved here. 

Aducanumab – which has had a controversial trial period to date – targets amyloid, a protein that forms abnormal clumps in the brains of people with Alzheimer’s that can damage cells and trigger dementia, including memory and thinking problems and communication issues.

In March 2019, late-stage international trials of aducanumab, involving about 3,000 patients, were halted when analysis showed it was no better, given as a monthly infusion, at slowing the deterioration of memory and thinking problems than a dummy drug.

But later that year, the US manufacturer Biogen analysed more data and concluded higher doses of aducanumab significantly slowed cognitive decline.

Charities have hailed the development as “promising” but stressed that it is the “beginning of the road”. 

“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,” says Dr Richard Oakley, head of research at Alzheimer’s Society. 

“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. As this drug will only benefit a proportion of people in the early stages of Alzheimer’s disease, there are hundreds of thousands more who may not be eligible, so we must keep searching for drugs for all stages of Alzheimer’s disease and for other types of dementia.”

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