How to access Leqembi before its EMA approval

After its accelerated approval in the USA in January 2023, Leqembi (lecanemab) has been a much-discussed treatment in the Alzheimer's world. As the fate of Leqembi's EU approval is also being decided ^[3], patients outside the USA have little choice but to wait.

But what if you can't wait? In this article, we'll look at the legal options you have to access Leqembi before its approval 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 is currently in review. A decision typically takes up to 210 days and should have been expected in late 2023 to early 2024. However, as of August 2024, there is no decision taken on Leqembi's EMA approval status. In the meantime, the MHRA in the UK approved lecanemab for use in early-stage Alzheimer's.

Medical community reactions to Leqembi

The medical community in Europe's response to Leqembi is 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 are the high cost of the medicine, as well as the considerable healthcare resources it requires for administration and patient monitoring ^[4]. 

Full approval on the FDA horizon?

While these concerns are being discussed, the outcome of Leqembi's EU approval application remains unclear.

In the meantime, Leqembi has received unanimous backing for full approval in the USA ^[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]. 

Whether a full approval by the FDA will have a positive impact on the EMA's decision on Leqembi, remains to be seen. 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 its EMA approval

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's EU approval. 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 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 its approval 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 its EU approval? 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 its EU approval 

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. 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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