Our letter to Matt Hancock on aducanumab

Today the FDA in the US made a landmark decision to approve the Alzheimer’s drug aducanumab. The drug has been approved under the FDA’s Accelerated Approval pathway, which includes a requirement for Biogen, the pharmaceutical company that makes the drug, to conduct a further stage four clinical trial to collect evidence on its benefits to patients.

We know that people with Alzheimer’s and their families around the world have waited almost 20 years for effective new drug treatments. For aducanumab to be available to patients in the UK, the UK regulators are carrying out their own independent and rigorous assessment of the data.

Today, I have written to the Health Secretary Matt Hancock, to ask him to speed up the UK evaluation process, to give people with Alzheimer’s in this country the answers they need.

You can read my letter below.

 

Dear Secretary of State,  

I am writing to you regarding the medicine aducanumab which today received licence from the US Food and Drug Administration (FDA) for treating people living with early stage Alzheimer’s disease. 

As you know, there are an estimated 850,000 people in the UK living with dementia, most commonly caused by Alzheimer’s disease, and it is the leading cause of death in England. The impact on people with dementia and on their loved ones is devastating. It is only the major condition currently with no treatment which can slow or stop the progression of the underlying diseases. 

We urgently need to see life-changing treatments available for people with Alzheimer’s disease and other forms of dementia in the UK. This is central to the mission of Alzheimer’s Research UK and I know it is an ambition you share. 

The FDA’s decision today is one which is of huge interest to people with dementia and their families as well as the research community. Given the urgent need of people with dementia in the UK, I am writing to call on the UK authorities to accelerate evaluation of aducanumab. 

Of course, we want to be sure that the regulatory authorities in the UK are confident that there is sufficient evidence to demonstrate aducanumab is both safe and effective. It is essential that the independent, evidence-based approach brought by the MHRA is maintained. However, COVID-19 has shown us that where there is leadership from government, high quality evaluation can be done more quickly. Such leadership is sorely needed in this area. 

We have seen considerable leadership from the government on dementia over the last few years, most recently in the manifesto commitment to double spending on dementia research and the welcome ambition to ultimately deliver a cure. 

We must go now further in ensuring the UK is a world leader in access to new dementia treatments. We would welcome your leadership in bringing together regulators, the NHS and the medicine’s manufacturer to provide speedy UK review of aducanumab, ahead of the European Medicines Agency decision expected in the autumn. 

In doing so the government would not only further demonstrate its commitment to people living with dementia, but also send a strong signal to the global life science industry regarding the UK’s preeminent status in medical research and healthcare innovation. 

I look forward to your consideration of this vital matter. Given the importance of this subject I will be making this letter available to our supporters. 

Yours sincerely,

Hilary Evans

Chief Executive, Alzheimer’s Research UK