The Medicines and Healthcare products Regulatory Agency (MHRA) has announced that it has approved donanemab, a new drug for Alzheimer’s disease. The National Institute for Health and Care Excellence (NICE) has published draft guidance against recommending that donanemab be approved for use on the NHS.
Britain’s biggest dementia charity, the Alzheimer’s Society, funded the research that first identified the role of amyloid plaques targeted by donanemab 30 years ago.
Reply to the announcement
Professor Fiona Carragher, chief policy and research director at Alzheimer’s Society, said:
“Disease-modifying treatments such as donanemab and lekanemab offer a new horizon of hope in the fight against dementia. The MHRA’s approval of donanemab is a new milestone on this journey, but it comes with a NICE draft decision not to recommend donanemab for use in the NHS. Although this is disheartening , we respect the regulator’s decision.
In other diseases, such as cancer, treatments have become more effective, safer and cheaper over time, and we hope to see similar developments in dementia.
About 20 Alzheimer’s drugs are in late-stage clinical trials, with more being sent for approval over the next few years.
New treatments are an important catalyst for change, but they are only one piece of the puzzle. As we prepare for the future, we must not forget the millions of people living with dementia in the UK today – a third of whom are undiagnosed.
We need to see significant government investment to bring about radical change so that everyone with dementia in the UK can receive an early and accurate diagnosis. Without this, people cannot use existing treatments and interventions to manage symptoms today or be prepared for tomorrow’s disease-slowing treatments.”