Research

What is lecanemab?

In August 2024, the Medicines and Healthcare products Regulatory Agency (MHRA) approved lecanemab (marketed as Leqembi in the UK) as a treatment for some people living with early Alzheimer’s disease. The drug can slow down the decline in memory and thinking skills of people living with early Alzheimer’s disease.

However, the National Institute for Health and Care Excellence (NICE) the regulatory body which considers whether new drugs are clinically and cost effective, shared guidance today that did not recommend lecanemab to be provided through the NHS. This means people will not be able to access the treatment through the NHS at this stage.  

There will be a month-long consultation on this guidance from NICE and a final decision, as to whether lecanemab may be provided through the NHS, made at a later date.  

The MHRA’s approval of the first safe and effective Alzheimer’s disease treatment, shown to slow progression, is a defining moment for people with early-stage Alzheimer’s disease in the UK and a significant step towards a more hopeful future.  

While we welcome the MHRA approval, it is disappointing that NICE has not recommended approving lecanemab for use on the NHS at this stage. The news that lecanemab will be restricted to certain groups of patients will also lead to uncertainty for many people with Alzheimer’s disease and their loved ones.  

We respect the decisions regulators have made, however we know these announcements will bring a mix of emotions for those who have been waiting a long time since the promising trial results were first announced.

The NICE recommendation reflects the urgent challenges which must be addressed regarding how we diagnose and treat people with dementia.

Now more than ever, Alzheimer’s Society is calling on Governments and health systems across the UK to prioritise dementia by improving early diagnosis in order to deliver ground-breaking treatments at scale.

Since the lecanemab announcement, another similar drug called donanemab, (marrketed as Kisunla) has been approved by the MHRA, but like lecanemab is not currently recommended for use on the NHS.  

What is lecanemab?

Lecanemab (brand name Leqembi) is a disease-modifying drug, which means that it was developed to tackle the causes of Alzheimer’s disease rather than only relieving the symptoms.

It targets a protein called amyloid. The importance of this protein in the development of Alzheimer’s disease was discovered by Alzheimer’s Society funded research led by Professor Sir John Hardy over thirty years ago. It laid the foundations for billions of pounds of investment into many drugs like lecanemab, with 127 other drugs currently being tested in clinical trials.

Lecanemab is a disease-modifying immunotherapy drug. Immunotherapies are already used in medicine, for example in the treatment of some cancers. More specifically, lecanemab is an antibody treatment. Antibodies already exist in the human body – they are a type of protein produced by the body’s immune system to fight against disease.

It uses antibodies to recognise amyloid in the brain and  works with the brain’s immune cells to clear amyloid protein build-up from the brains of people living with early-stage Alzheimer’s disease. These amyloid protein build-ups are thought to be toxic to brain cells, causing them to get sick and eventually die, leading to the symptoms of Alzheimer’s disease.  

Lecanemab is given to patients intravenously, which means into a vein through a drip bag.
 

How can I access lecanemab?

The MHRA has granted a license for lecanemab to be available in the UK. In the UK, lecanemab is marketed under a brand name Leqembi.

The MHRA has approved lecanemab for people at the early stages of Alzheimer’s disease. This excludes:  

• people with moderate or late-stage dementia caused by Alzheimer’s disease
• those with other forms of dementia such as vascular dementia, Lewy body dementia or frontotemporal dementia
• people who carry two copies of the APOE4 gene variant

The MHRA makes decisions based on the safety and effectiveness of drugs, and in their review of the available data, have chosen to make these exclusions due to the higher risk of side effects in these individuals.

It is possible lecanemab may be available through private health providers. 

Will it be available on the NHS?

Whilst the MHRA has approved lecaneamb, draft guidance from NICE has not recommended it for use on the NHS at this stage.   

The National Institute for Health and Care Excellence (NICE) decide which medicines should be made available on the NHS. They have announced that lecaenamb does not meet their criteria for clinical and cost effectiveness for use on the NHS.  

There will be a consultation on this guidance and a final decision on whether lecanemab might be made available on the NHS will be made at a later date. 

Is the NHS ready to administer a drug like lecanemab if approved by NICE?

The approval of lecanemab by the MHRA is a defining moment for dementia. However, the NICE recommendation reflects the urgent challenges which must be addressed regarding how we diagnose and treat people with dementia.

Lecanemab is most effective in the early stages of disease, therefore it is important to diagnose Alzheimer’s disease early. Currently more than a third of people with dementia don’t get a diagnosis, and for people who do, evidence suggests that on average people live with dementia for 3.5 years before being diagnosed.  Alzheimer’s Society is calling on the NHS in England and Wales and the HSC system in Northern Ireland to publish plans for how they will transform diagnosis and deliver new treatments. 

At Alzheimer’s Society we are determined to help people access support, diagnosis, and treatment they need. We have launched the Blood Biomarker Challenge with the aim of revolutionising dementia diagnosis. You can read more about these blood tests here. 

Does lecanemab work?  

The MHRA’s decision to approve lecanemab shows that it is safe and effective for use as treatment of early-stage Alzheimer’s disease. The MHRA will have reviewed results from clinical trials to make their decision.

The clinical trial was carried out by Eisai. The results of lecanemab’s phase 3 clinical trial, called Clarity-AD, were shared at the Clinical Trials on Alzheimer’s Disease (CTAD) conference in San Francisco.

Clarity-AD was a phase 3 clinical trial involving 1,795 people. The trial involved people living with early-stage Alzheimer’s disease who have amyloid protein build-ups in their brains. Half the participants were given lecanemab and half received a dummy drug over 18 months.

The trial showed that lecanemab slowed down the speed at which memory and thinking skills got worse by 27% in people taking the drug compared to people on the dummy drug.

The research team also found that the drug reduced loss of quality of life by up to 56%.

Importantly, the drug reduced the amount of amyloid protein present in the brain. Amyloid protein levels were also reduced in the blood and spinal fluid.  

Is lecanemab safe?

As part of the approval process, the MHRA scrutinised the lecanemab safety data and decided that lecanemab is both safe and effective as a treatment for early-stage Alzheimer’s disease. However, like all drugs, lecanemab was found to have some side effects. Some of these side effects are serious.

During the clinical trial, some people taking lecanemab experienced reactions to having the drug infused, while some others were found to have swelling or microbleeds in the brain in response to lecanemab. These are known as Amyloid Related Imaging Abnormalities or ARIA. There have also been three deaths related to taking lecanemab in the clinical trial and extension phase. This is less than 0.2% of the participants in the trial. The majority of people who experienced ARIA had no symptoms and these changes in the brain were only detected using MRI brain scanning.

The MHRA will continue to monitor the safety and effectiveness of lecanemab in the future. Patients who receive lecanemab as treatment can report any adverse effects through MHRA’s Yellow Card Scheme.  

Are there other treatments available?

Currently, there is no cure for dementia. However, we are at an exciting time in dementia research and there are promising new drugs on the horizon.

Along with lecanemab, another drug that targets amyloid, called donanemab has also been approved by the MHRA for use in the UK.  Like lecanemab, donanemab  is not currently recommended for use on the NHS.  

Successful clinical trials have confirmed our understanding of the underlying disease mechanism, helping us to target future research to develop new and better treatments that are more effective, easier to administer and with fewer side effects. Lecanemab will be succeeded by many more dementia treatments.  

There are 127 drugs currently in clinical trials.  

Patients can also access medications to ease dementia symptoms, as well as other treatments and support that do not involve medication, such as talking therapies. You can read more about alternative treatment options here.  

How can I access further support?  

The news about lecanemab might be overwhelming. No matter the issue, we are here for you. You can access our dementia support services on our website.  

We also operate a dementia support line, where you can access personalised information, support, and advice. Phone support is available 7 days a week by calling 0333 150 3456.  

We will update this page as new information becomes available. Last updated: [23 October  2024]