FDA approves new Alzheimer's disease drug donanemab in the US

The Food and Drug Administration (FDA) has announced its approval in the US of the drug donanemab, a ground-breaking new treatment for early Alzheimer’s disease.  

Fiona Carragher, Director of Research and Influencing at Alzheimer’s Society, said: “Donanemab is now the third drug aiming to slow down Alzheimer’s disease to be approved in the US, marking another step forward in the fight against dementia, the biggest health and social care challenge of our time. 

We’re proud that Alzheimer’s Society funded research over thirty years ago which identified amyloid as important in the development of Alzheimer’s disease and has led to this moment today.  

What does this mean for people in the UK?

“People affected by Alzheimer's disease in the UK will wonder what this means for them - particularly as regulators did not approve aducanumab, which was also approved in the US a few years ago. 

There are still many hurdles before donanemab could be available on the NHS. 

"We now need to wait for the UK regulatory authority, the Medicines and Healthcare products Regulatory Agency (MHRA), to conduct its review of the donanemab data, and for The National Institute for Health and Care Excellenc (NICE )to evaluate its cost-effectiveness.  

“This drug is only suitable for people in the early stages of Alzheimer’s disease, and until we fix dementia diagnosis in the UK, only small numbers of people will get the early, accurate diagnosis needed to access the treatment if it’s approved here. 

"Right now, a third of people with dementia in the UK do not receive a diagnosis at all, so we need to see urgent investment into the specialist workforce and equipment needed to diagnose as many people as possible."

A call to the NHS

“Donanemab is just one of nearly 130 potential treatments for Alzheimer’s disease being tested in trials, so it’s paramount we ramp up preparation for their arrival and roll-out.  

“Alzheimer’s Society is urgently calling on the NHS to publish plans for how they intend to improve early diagnosis and deliver new treatments to the people who desperately need them."