Alzheimer's Society responds to MHRA and NICE announcements on donanemab

The Medicines and Healthcare products Regulatory Agency (MHRA) has announced approval of the drug donanemab, a new treatment for Alzheimer’s disease. The National Institute for Health and Care Excellence (NICE) has published draft guidance which does not recommend that donanemab is approved for use on the NHS.

The UK’s largest dementia charity, Alzheimer’s Society, funded the research which, 30 years ago, first identified the role of the amyloid plaques that donanemab targets. 

Response to the announcement

Professor Fiona Carragher, Chief Policy and Research Officer at Alzheimer’s Society, said:  

"Disease-modifying therapies like donanemab and lecanemab offer a new horizon of hope in the fight against dementia. MHRA’s approval of donanemab marks another milestone in this journey, but it comes alongside a draft NICE decision not to recommend donanemab for use on the NHS. While this is disheartening, we respect the decision of the regulator.

In other diseases like cancer, treatments have become more effective, safer and cheaper over time and we hope to see similar progress in dementia.

With around 20 Alzheimer’s disease drugs in late-stage clinical trials, more drugs will be submitted for approval within the next few years.

New treatments are an important catalyst for change, but they are only one piece of the puzzle. While preparing for the future, we must not lose sight of the million people living with dementia in the UK today – a third of whom don’t have a diagnosis.

We need to see significant government investment to bring about radical change so that everyone with dementia in the UK can get an early and accurate diagnosis. Without this, people won’t be able to access existing treatments and interventions to help manage their symptoms today or be ready for the disease slowing treatments of tomorrow."

Making dementia a priority

Now more than ever, Alzheimer’s Society is calling on Governments and health systems across the UK to prioritise dementia by improving early and accurate diagnosis.

We know first-hand the devastation that dementia causes and would encourage anyone with dementia or concerns about potential symptoms to contact Alzheimer’s Society for support.