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Leqembi is the brand name of Lecanemab, a ‘breakthrough’ Alzheimer’s drug. It is specifically designed for this purpose, and is given via intravenous infusion (providing a drip feed of fluids into a vein, usually in the arm) once every two weeks.
Patients with Alzheimer’s usually have an increased amount of amyloid protein around neurons in the brain, which can inhibit the mental functioning of the individual (thus presenting worse symptoms of Alzheimer’s). The goal, therefore, was to find a way to remove these amyloid proteins. Lecanemab contains antibodies which stick to the proteins, then ‘call in’ the immune system to help break them down. The result is neurons which can continue to function effectively for a longer period of time – this drug has been shown to delay the onset of Alzheimer’s for a few months.
This is not an entirely new process, it should be noted. a rival drug from US pharmaceutical giant Eli Lilly works via a fairly similar process (but with far less promising data in terms of outcomes – hence the reason for all the hype around Leqembi so far).
The team behind Leqembi is a collaboration between Japanese pharmaceutical firm Eisai and a US collaborator, BioArctic. Eisai currently hold the exclusive global rights to manufacture and market the drug.
Looking at the data from trials so far, the drug has slowed cognitive decline by around 27% when provided across a course of 18 months. It is worth noting that the trials so far (and the way the drug is being marketed) have been focused solely on early stage Alzheimer’s patients, however. It is likely that the effects are far less potent further down the line.
At the same time, there have been a number of side effects reported too. Amyloid-related imaging abnormalities (ARIA) have shown up on MRI scans, including issues as serious as swelling and bleeds on the brain. These outcomes have led to some concerns amongst regulators across the world.
The majority of responses have been generally positive, to be clear.
In the US, the FDA (Food and Drug Administration) approved the drug back in 2023. Thousands have already received the treatment in America, generating over £100 million of revenue (almost exclusively from the US market).
The drug has also been rapidly approved in a number of Asian markets, including both Japan and China.
In Europe, however, the response has been quite different. The European Medicines Agency (EMA) rejected Leqembi’s licence application last month (which was planned to bring in over a billion dollars in sales for Eisai and Biogen – note the Biogen share price drop of almost 6% following the announcement). This means that it is very likely Leqembi will be unavailable in the EU’s 27 member states.
The main reason given by the EMA was a concern over side effects. As already mentioned, they are relatively significant – the EMA stated that ‘some patients had serious events, including large bleeds in the brain which required hospitalisation’. They added that ‘the seriousness of this side-effect should be considered in the context of the small effect seen with the medicine’. In short, then, the EMA does not feel that the temporary slowing of early-onset Alzheimer’s for a few months is worth the risk of the rare (though serious) side effects, which have reportedly proven fatal in at least one case already.
Eisai have announced their plans to challenge the EMA’s decision, which they described as ‘extremely disappointing’. Industry experts are suggesting that the appeal may be successful – around 40% of EMA rulings against new drugs are later reversed as new data is gradually brought out following further testing.
The UK medicines regulator, MHRA, has officially licensed the drug for use in the UK. However, health assessment body NICE have determined that the drug should not be available on the NHS (meaning only private patients may be able to access it). They did reference the limited efficacy of the drug in contrast with its potentially serious side effects, though really leaned into economic points more in this case.
In the US, the drug costs around £20,000 per patient each year, and the NHS (which cares for 70,000 adults in England alone who would have been eligible for the treatment) feels that the cost would simply be poor value for money with those considerations in mind. This is especially given the already precarious state of NHS finances, a regular political talking point.
Even the MHRA have put some restrictions on their licence – people ineligible for treatment would include those on blood thinners or anyone with two copies of the E4 gene (around 15% of the population, so a significant number of potential patients).
While these decisions are technically limited to England, Wales and Northern Ireland historically follow their lead on such decisions (while Scotland will likely conduct their own assessment and come to their own conclusions).
It is also worth noting the response to the NICE decision. Various UK Alzheimer’s charities have expressed disappointment at the news the drug will not be available on the NHS, and urged NICE to reconsider.
There are many points for aspiring lawyers (both solicitors and barristers) to consider here. These would form great discussion points – both on initial written application forms and then interviews further down the line.
In terms of relevant practice areas, Public Law is obviously prevalent here. These are legal experts in the field of challenging governmental-type decisions (and will be involved over in Europe when Eisai bring their appeal to the EMA, for example).
Drugs like these are also very important sources of income for patents lawyers. At top law firms involved in IP (intellectual property), for example, the registration and protection of processes for creating novel treatments is an incredibly lucrative industry. STEM students are often particularly in demand here given the technical nature of the work.
Generally, lawyers working on cases related to Leqembi would also need a good grasp of international law. Since the drug has been both licensed and rejected in various regions, lawyers bringing appeals on behalf of Eisai against decisions will likely need to collaborate with lawyers abroad (perhaps from another office within the same law firm, if the organisation has a large enough footprint). This will require an understanding of different legal processes and analysing whether certain principles are applicable cross-jurisdictionally.
More broadly, aspiring lawyers could think about the public sentiment around such important issues as Alzheimer’s treatments, and consider how such sentiment will influence business decisions around the drug in different territories (demonstrating commercial awareness in the process).
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