What?
A pioneering treatment for Alzheimer’s disease, aducanumab, has been rejected by the EMA (European Medicines Agency) for approval in territories, due to a lack of proven benefit.
Alzheimer’s disease is a form of dementia. It is a gradual and often irreversible development of symptoms such as memory loss and confusion. It is generally accepted to be caused by the build-up of amyloid beta plaques in the brain. These plaques are formed of protein and are not usually found in large numbers in the brains of healthy people.
Aducanumab (Aduhelm) is a drug designed to reduce the amount of these plaques in the brains of patients with Alzheimer’s disease.
Why?
Aducanumab was first accepted for medical use by the FDA (Federal Drug Agency), the USA’s equivalent of the EMA. This was the result of a controversial ‘fast-track’ process. The main studies involved in testing the new drug initially showed little effect on plaque removal, but then later analysis did show some positive findings. A panel of experts reviewing the evidence did not find that aducanumab was effective and would not recommend its approval. However, the FDA still went on to approve it, and three panel experts resigned from their posts in protest.
The EMA agreed with the findings of expert panel. Due to the significant cost of the drug (£42,000 per person per year) and lack of positive findings, the EMA did not approve the drug. It was also shown to cause harm in some patients e.g. brain swelling and bleeding.
Although the EMA did agree it reduced the amount of amyloid plaque, they did not agree that this had a significant effect on slowing the progression of Alzheimer’s.
How (does it affect you?)
The EMA approves medicines in the EU, and the FDA covers the USA. In the UK this role is undertaken by the Medicines and Healthcare products Regulatory Agency (MHRA). This is advised by NICE (National Institute for Clinical Excellence). However, the EMA’s rejection will likely have a knock-on effect as to whether we will accept it. The UK review process has been ongoing since September 2020, and is likely to finish in May 2022.
The MHRA has not yet approved this drug, and it is not currently available on the NHS. This news does not change current Alzheimer’s practice in the UK.
If you or your loved one suffer from Alzheimer’s this news will come as a setback. Alzheimer’s disease has very few effective treatments, and there are no treatments that can cure the disease, they can only slow it down. It was hoped that aducanumab would remove what causes Alzheimer’s at source – yet current evidence shows this may not be enough. It was also aimed at sufferers in the early stages of their disease, meaning many thousands with advanced dementia would not be eligible.
But, the future may be bright. There are hundreds of Alzheimer’s treatments in the pipeline that may help patients in the future, all focusing on different ways to prevent disease progression. Watch this space for new developments.
If you or your loved one has Alzheimer’s, it is worth speaking to your GP to request a referral to an old-age psychiatrist. They are doctors who specialise in mental health of older people, and may be able to offer specialist treatments to help the symptoms of Alzheimer’s, and keep the brain healthier for longer.
Often people with dementia may need a lasting power of attorney or a home visit. Click the links to find out more about these key topics from our writers at myHSN.
As always, best wishes from myHSN. And Happy Christmas.
*myHSN does not replace medical advice of your healthcare provider, and as always, if you are unwell or need medical attention, please dial 111, or 999 in an emergency*
