Regulators across the world are grappling with what to do about new medicines for early Alzheimer’s disease. Today, an expert committee for the European regulator the European Medicines Agency (EMA) decided not to approve lecanemab (also known as Leqembi) for the treatment of early Alzheimer’s disease, as in its view, the benefits were not large enough to outweigh the risks. 

At Alzheimer’s Research UK, we’re keenly keeping track of how lecanemab is being scrutinised by global regulators. The drug has already been approved in the US, Japan, China, Hong Kong, Israel and South Korea, but today’s news from the EMA committee will mean that patients in the EU will not be able to receive it in the near future.   

The impact for people with Alzheimer’s in Europe 

While we’re eagerly awaiting news from the MHRA, this week our attention’s been focused on the EMA, and its two-step process. 

The first step in the EMA’s decision-making process is taken by a body called The Committee for Medicinal Products for Human Use (CHMP) – the EMA’s committee responsible for assessing medicines. This week, it met to look at the data on lecanemab, in order to make a recommendation over whether it should be granted an EU license.  

A license – if granted – would allow lecanemab’s manufacturer, Eisai, to legally sell the medicine in these countries, and healthcare professionals to legally prescribe it to people with a diagnosis of mild cognitive impairment or early Alzheimer’s. 

Lecanemab, which targets the amyloid in the brain that are one of the main characteristics of Alzheimer’s disease, also carries a risk of serious side effects including brain bleeds and swelling. 

The Committee, which is made up of scientific experts from all EU member states, ruled that the ‘’effect of Leqembi on delaying cognitive decline does not counterbalance the risk of serious side effects associated with the medicine.’’ 

In other words, the committee does not think the benefits of taking the drug outweigh the risks due to side effects.  

The committee’s recommendation will now go on to be considered by the European Commission, an arm of the European Union, who will make a final decision as to whether to grant the drug a license for the EU .  

The significance of today’s decision is reinforced by the fact that the European Commission follows the opinion of the CHMP in “almost all cases”, according to the EMA’s website.  

“Lecanemab is not a cure for Alzheimer’s disease,” said Prof Jonathan Schott, Chief Medical Officer at Alzheimer’s Research UK “but evidence from clinical trials suggests that it can slow progression in people with mild forms of the disease, in whom it leads to benefits in quality of life and reduces impact on carers.”  

“While it is of course vital to balance benefits and potentially serious side-effects, the EMA’s recommendation runs counter to the decision reached by other G7 nations like the US and Japan, whose regulators have already given the green light to this drug and have embedded risk management plans to address potential side effects.”  

“Attention will now turn to the UK’s regulator – the MHRA – which is expected to announce a decision on lecanemab imminently. This announcement can’t come too soon for people with Alzheimer’s disease in Great Britain who for now must wait while other countries forge ahead with innovative medicines.” 

In light of today’s announcement Eisai has said that it will seek “re-examination of the CHMP opinion and work with the relevant authorities to ensure this treatment is available for eligible people living with early AD in the European Union (EU) as soon as possible.’’ 

What did the committee base their recommendation on? 

The committee’s review was based on the results of the global CLARITY-AD study, which showed that lecanemab was able to slow cognitive decline in early Alzheimer’s patients by 27% compared to placebo. This effect was observed over 18 months, with ongoing studies investigating lecanemab’s efficacy over longer durations. However, the long-term effects remain unknown for now. 

The Committee also considered lecanemab’s potential side effects, which for some can be serious, such as the risk of brain swelling or bleeding. There remain unanswered questions about these side effects, including whether they can become more serious over time. That’s why the risk associated with lecanemab is something which is being closely monitored in longer-term studies, and is being taken into account by regulators across the world when deciding whether to approve the drug. 

Deciding whether the benefits of a new drug outweigh its potential risks is not an easy task – and the CHMP did call in a Scientific Advisory Group (SAG) to assist with its review of lecanemab. SAG meetings provide independent advice when there are differing views or split opinions within the CHMP. In 2021, a SAG meeting was also convened to address concerns about another amyloid-targeting Alzheimer’s drug called aducanumab. That process resulted in a decision to turn down the marketing application, despite the medicine being approved in the US. However, the arrival of lecanemab means the development and sale of aducanumab has since ceased.  

What happens next? 

Whilst decisions are taking place in the European Union, lecanemab is also under review with Great Britain’s regulator, the Medicines and Healthcare products Regulatory Agency (MHRA). A decision for Britain is expected over the coming weeks, although it’s important to state that the CHMP’s recommendation has no bearing on that outcome. 

Reflecting on the decision, Prof Schott said ‘While disappointing, today’s news is a reminder both of how far we have come, and how much work there still is to do. Research has led to huge advances in our understanding of how Alzheimer’s disease starts and develops, and ever better ways of making an early and accurate diagnosis. 

“There are now more than 160 clinical trials underway testing over 125 experimental treatments for Alzheimer’s across the globe, with over 30 in the final phase of development. It really is a matter of when, not if, we can offer people with dementia the new treatments they so desperately need.” He continued.  

If you have any questions about lecanemab, today’s recommendation or when the drug might be available to you or a loved one, you can contact our Information Services team on 0300 111 5 111 (9.00-5.00pm Monday to Friday – excluding bank holidays) or email infoline@alzheimersresearchuk.org.  

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