US regulator grants accelerated approval for Alzheimer’s drug lecanemab

policymakers-resized

By Robin Brisbourne | Friday 06 January 2023

It’s been less than two years since the US Food and Drug Administration (FDA) approved the first licence of a new drug for Alzheimer’s disease in a generation. But that drug, aducanemab, became a source of controversy, and was not approved for use in Europe by the European Medicines Agency (EMA).

Now, the US regulator has granted a licence for another anti-amyloid drug – lecanemab (known commercially as Leqembi). This is the drug which first made headlines in the UK last September, and around which the data is far more clear cut.

Today’s ruling means doctors can now prescribe lecanemab to people living in the US with a confirmed diagnosis of mild cognitive impairment (MCI) or early-stage Alzheimer’s disease, who have appropriate medical insurance, or can afford to pay for it directly.

What does this mean for people living with Alzheimer’s in the UK?

Today’s decision marks another important milestone in the global effort to bring about treatments that target the underlying diseases of dementia. Yet we know for many of our supporters in the UK, this news may prompt mixed emotions and raise new questions about when the drug might be available here.

As highlighted in our animation below, there are many hurdles ahead that need to be cleared before this can happen. This period of uncertainty, while we wait for a decision from the UK drug regulators, may be difficult for individuals with Alzheimer’s and their loved ones. That’s why we’ve written to Eisai, lecanemab’s manufacturer, calling on them to work with the UK government, UK regulators and the NHS to ensure an evidence-based decision on lecanemab’s safety and efficacy can be made as a matter of urgency. Eisai is expected to file an application for marketing-authorisation in Europe by the end of March 2023.

Set against this, it’s also clear that lecanemab can cause side effects which can, for some, be extremely serious. Decisions as to whether the benefits of any drug outweigh its risks, who should or should not be offered treatment, and how individuals should be counselled to make an informed decision are vital parts of the development and regulatory approval of all drugs. As we now look ahead to what outcome may prevail in the UK, the UK regulators will look independently at the full clinical trial data to ensure that lecanemab is safe, effective and brings real improvements to people’s day-to-day lives.

There is still much work to do

Making sure our health system is set up to deliver life-changing treatments to people as quickly as possible, with all the necessary clinical monitoring in place, must be a priority. Following the launch of the Dame Barbara Windsor Dementia Mission, we truly believe this country is well placed to lead the adoption of innovative new dementia drugs, and we look forward to working with the Mission team to ensure the NHS is ready.

Lecanemab gives the research community great confidence that we will, one day, be able to deliver a range of treatments that tackle different aspects of Alzheimer’s, as well as other diseases that cause dementia. Researchers worldwide, including those funded by Alzheimer’s Research UK, are working hard to bring these forward. There are now more than 140 experimental drugs in clinical testing today, and we firmly believe that significant advances in dementia treatments will prevail over the next decade.

If you have questions about lecanemab, we hope you can find the answers you’re looking for in our updated blog post, written by the staff who run our Dementia Research Infoline. They can also be reached on 0300 111 5 111 (9-5pm Monday to Friday).

About the author

Robin Brisbourne