How to access Leqembi before it's available across the EU

After its accelerated approval in the USA in January 2023, Leqembi (lecanemab) has been a much-discussed treatment in the Alzheimer's world. Leqembi's EU approval has taken a long time to become a fact, but in November 2024, the CHMP announced its positive recommendation for the medicine. This being said, patients across the EU aren't going to have access to lecanemab immediately. Until EMA approval becomes official and each individual EU member state launches it locally, patients could wait between a couple of months and a couple of years. 

But what if you can't wait? In this article, we'll look at the legal options you have to access Leqembi before it's available in Europe. 

Leqembi approval in the EU: What's the current status?

In January 2023, Leqembi's manufacturer, Eisai, submitted its marketing authorization application to the European Medicines Agency (EMA) ^[3]. The application was in review until July 2024, when the EMA initially rejected it. In the meantime, the MHRA in the UK approved lecanemab for use in early-stage Alzheimer's. Perhaps inspired by the UK's decision, and after a reevaluation requested by Leqembi's manufacturer, the EMA announced in November 2024 that it will approve lecanemab for use in early-stage Alzheimer's patients.

Medical community reactions to Leqembi

The medical community in Europe's response to Leqembi has been similar to that of their colleagues in the USA.

Soon after the FDA granted accelerated approval to Leqembi, US researchers published an open letter to express their concerns about the medicine ^[1]. The main caution they voiced was related to the potential adverse effects of Leqembi. In their opinion, risks may not be justified by the drug's efficacy, which they referred to as "below that accepted as clinically meaningful" ^[1]. 

European neurologists and medical professionals have expressed similar concerns ^[4]. Additional considerations within the EU have been the high cost of the medicine, as well as the considerable healthcare resources it requires for administration and patient monitoring ^[4]. 

Full approval by the FDA

While these concerns caused a wide discussion across the Alzheimer's community, Leqembi received unanimous backing for full approval in the USA, which became a fact soon after ^[5].  The head of the agency's Office of Neuroscience, Teresa Buracchio, has confirmed that the FDA sees Leqembi's benefit as "clinically meaningful". According to Buracchio, the drug's value is in extending the time a patient spends in the early, less severe phase of Alzheimer’s disease ^[5]. 

While this has been positive news and has likely been a factor in the EMA's approval of lecanemab, the fact is that the medicine is not yet available in Europe. For patients with cognitive impairment who need the treatment right now, there are some options to avoid the waiting. 

Ways to safely access Leqembi before it's available in Europe

Are you an early Alzheimer's patient? If your doctor is of the opinion that you might benefit from treatment with Leqembi, you may not need to wait for Leqembi to become available in your country. Instead, your doctor and you could consider joining a Leqembi clinical trial. Or, buying and accessing the medicine on an Individual Named-Patient basis.

Access Leqembi via a clinical trial

One way to access Leqembi (lecanemab), or other medicines that aren't approved or available in your country yet, is to enroll in a clinical trial. This can often be easier said than done, as you and your doctor would need to find a trial that is currently recruiting participants in your country. You would also have to meet their eligibility criteria. For all of this, you will need your treating doctor's support. 

Here are some good places to start looking for ongoing Leqembi (lecanemab) clinical trials:

• ClinicalTrials.gov: This is a database with all clinical trials in the USA. Some of the trials are also open to international participants. An example is the AHEAD 3-45 clinical trial with Leqembi. It's US-based, but also open to patients in the UK, Sweden, Spain, Australia, and other countries ^[6].
• EUClinicaltrials.eu: This is a database with all clinical trials in the European Union. Currently, it contains limited information on trials launched before 31 January 2022. For those trials, you can refer to the EU Clinical Trials Register. 
• myTomorrows: This organization supports patients in finding treatment options in clinical trials. 

Buy Leqembi on a Individual Named-Patient basis

In most countries, patients are legally allowed to buy and import medicines that could enhance their quality of life or address life-threatening conditions. If you want to access Leqembi before it's available in Europe, this might be an option for you and your doctor.

The regulation making this possible is known as the Individual Named Patient Import regulation. There may be variations across countries in terms of the specific administrative requirements. However, in all cases these criteria must be met:

• The medicine in question has market approval in another country and is not (yet) approved or available in the patient's country;
• There is no alternative on the local market;
• The medicine is for personal use;
• The patient has a prescription letter from their treating doctor;
• The doctor takes responsibility for the treatment. This might require different documentation from country to country.

Do you want to use the Individual Named Patient Import regulation to get Leqembi before it's widely available? You will first need to consult your treating doctor and get a suitable prescription.

Already have a prescription? Our team can support you with sourcing Leqembi for you. We specialize in sourcing and delivering medicines not yet approved where you live across the world on a Named-Patient basis. Get in touch with us for more information. 

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Final thoughts on accessing Leqembi before it's available in Europe

For any patient facing cognitive decline, the possibility of delaying the progression of the disease can be priceless. 

Approval processes for Leqembi in Europe and elsewhere are slow. And getting the approval is not the final stage. Speeding access might seem attractive. However, there are also serious side effects for Leqembi you need to get yourself informed about by your doctor. If after being well-informed you and your doctor decide to try and access the medicine, there are always options. 

Reach out to our team for help. Whether you want to explore a clinical trial or buy Leqembi on a Named-Patient basis, having your doctor on board is very important. For resources to help you in conversations with your treating doctor, check out more of our articles.

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