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Reactions to the approval of lecanemab for the treatment of Alzheimer's patients in the US

The drug lecanemab (Leqembi™) has received full approval as a treatment for early Alzheimer's disease by the US Food and Drug Administration (FDA), after confirming its clinical benefit in a trial involving 1,795 patients. The FDA highlights the warning that in rare cases it can cause serious and potentially life-threatening side effects.

07/07/2023 - 09:03 CEST
Expert reactions

Paresh Malhotra - lecanemab

Paresh Malhotra

Head of the Division of Neurology, Imperial College London; and Consultant Neurologist, Imperial College Healthcare NHS Trust.

Science Media Centre UK

The approval of Leqembi by the United States FDA is a major step.  The ‘black box’ warning indicates the importance and potential severity of the side effects of the drug, which are linked to patients’ genetics and also whether they are taking blood thinners.  The informed consent process will be critical to the prescription and delivery of Leqembi, and genetic testing will be part of that.  All this will raise a number of issues for what may happen in the NHS, and if Leqembi is approved here, then services will need to be very carefully designed to provide assessment, careful and honest informed consent, regular infusions and monitoring scans, as well as dealing with the side effects of brain swelling and bleeding.

The author has not responded to our request to declare conflicts of interest

John Hardy - lecanemab

John Hardy

Professor of Neuroscience and Group Leader at the UK Dementia Research Institute, UCL.

Science Media Centre UK

This is clearly great news and heralds a sea change in our views about Alzheimer’s disease: there are now drugs which all agree slow the underlying disease process.  This, from Eisai, is the first, and it is likely that the equivalent drug from Lilly is close behind.  Safe administration of these drugs to the appropriate patient group will pose an organisational challenge to the NHS, but this is wonderful news.  It is worth noting that the UK Alzheimer charities funded the original work leading to this breakthrough and are now funding initiatives to help prepare for appropriate patient identification.

Conflicts of interest: “I have consulted for Eisai and Lilly.”


David Curtis - lecanemab

David Curtis

Honorary Professor, UCL Genetics Institute, UCL.

Science Media Centre UK

This really is remarkable news.  Certainly there are concerns about serious side effects and questions about the balance between clinical benefits and the overall costs of treatment.  Nevertheless, this decision badges Alzheimer’s disease as an illness which can potentially be treated or prevented, rather than simply endured.

The author has declared they have no conflicts of interest

Hilary Evans -lecanemab

Hilary Evans

Chief Executive at Alzheimer’s Research UK.

Science Media Centre UK

This welcome news from the US signals a step towards a world where Alzheimer’s disease is treatable, but should also serve as a wake-up call.

Today’s ruling involved careful review of data from a rigorous study of 1,800 patients.  A similar process is currently underway in the UK, led by the Medicines and Healthcare products Regulatory Agency (MHRA).  We’ve written to the MHRA urging them to complete this review as a matter of urgency, without compromising on quality, so people with Alzheimer’s in the UK aren’t left in limbo.  We believe that a rapid regulatory decision on lecanemab will further strengthen the UK’s international reputation as a leader in dementia, attract even greater commercial investment in UK clinical trials, and ultimately benefit the one in two of us who will either develop dementia in the future, or care for someone who has it.

With a UK decision on the horizon, today’s news underlines the urgency of getting the NHS ready for new medicines like lecanemab.  There are several barriers that need to be tackled, starting with an overhaul of the way dementia is diagnosed.  People won’t be able to access these drugs without a confirmed diagnosis of Alzheimer’s, but this is primarily done using a PET scan and the UK has one of the lowest numbers of scanners per capita in the developed world.  We’re concerned that, without action, this would significantly restrict access and create inequities in care.

Looking further ahead, new diagnostics are on the horizon – blood tests for Alzheimer’s have been developed, and we’re supporting research to hasten their use in clinical practice.  So lecanemab’s potential arrival should act as a warning to accelerate work on this front, and help ensure people who could benefit from these new medicines are identified quickly.

Progress for people with Alzheimer’s disease is long overdue.  As a first-generation treatment, lecanemab’s effects are modest – a 27% slowing of progression over 18 months – and it comes with side effects that can be serious.  Science can, and must, do better – both in terms of delivering drugs that are even more effective, with fewer side effects, and also treatments for people with later stage Alzheimer’s and those with other forms of dementia.  At Alzheimer’s Research UK, we will work tirelessly to help bring about a world free from the heartbreak of dementia, and for a cure for the diseases that cause it.

The author has not responded to our request to declare conflicts of interest
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