2024-03-21 09:36:00
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The drug has been on the market in the USA since last year. Michael Clevenger/CourierJournal/Imago © IMAGO/USA TODAY Network
The European Medicines Agency is examining whether Leqembi will also be approved in the EU after the USA. But the drug only works for mild memory disorders.
Frankfurt – The antibody lecanemab can reduce the formation of plaques of the protein amyloid beta in the brain and slow the progression of Alzheimer’s dementia – if it is given at a very early stage. In the USA, the FDA approved the drug with the trade name Leqembi last year. Experts there spoke of a milestone. It was developed by the pharmaceutical companies Eisai (Japan) and Biogen (USA).
The European Medicines Agency Ema is currently examining approval for the EU. The decision is expected in the first half of the year, possibly even in the next few days. The responsible committee for human medicine must weigh up whether the clinical benefit for the – relatively – small group of patients diagnosed with early-stage Alzheimer’s justifies the high cost of regular infusions – and, above all, whether it outweighs the risk of possible side effects .
Leqembi addresses the fundamental mechanisms of Alzheimer’s disease
If Leqembi were to come onto the market in the EU, it would be the first drug to address the fundamental mechanisms of Alzheimer’s. However, it cannot achieve a cure. The condition is still deteriorating, just more slowly.
Lecanemab is an active ingredient from the group of monoclonal antibodies. These are proteins that target a specific structure, in this case the protein amyloid beta. It is considered one of the “major players” in driving Alzheimer’s disease by forming clumps in the brain. Lecanemab binds to soluble amyloid beta molecules and can therefore prevent the formation of new plaques, but not dissolve existing ones. This is the reason why Lecanemab is only suitable for patients at an early stage.
Alzheimer’s is usually only recognized when the damage has progressed
The main problem here is that the disease is usually only recognized when the damage to the brain is already well advanced. The development of simple, reliable tests is just as important as that of therapies. So far there is only one safe biomarker in the blood; a corresponding test could come onto the market in the next few years.
In a phase 3 study with 1,795 participants, lecanemab delayed the progression of the disease by 27 percent. In 17 percent of the test subjects, edema in the brain occurred while taking it, but in most cases this was symptom-free. Experts emphasize that close monitoring is still necessary. This also applies to microbleeds in the brain that can occur during therapy.
Therefore, treatment is contraindicated or should be considered very carefully in people with an increased risk of bleeding (including through medication) and an increased risk of stroke. The medication is administered every two weeks by infusion, each lasting one hour. In the USA, this happens in doctor’s offices or special infusion centers.
Alzheimer’s drug Leqembi: Expert warns against “false hopes”
One of the biggest difficulties after possible approval will be filtering out those patients for whom therapy is an option. Katharina Bürger, head of the memory clinic at the Institute for Stroke and Dementia Research at the Ludwig Maximilians University in Munich, put the number in Germany at around 20,000 during a discussion at the Science Media Center. The number of people who want to get the drug is likely to be far higher, she suspects.
Frank Jessen, head of the Clinical Alzheimer’s Research Working Group at the German Center for Neurodegenerative Diseases, shares this assessment. Some patients have already requested treatment as self-payers or even traveled to the USA to have the infusions administered there.
For Germany, Katharina Bürger calls for careful selection and warns against “false hopes”. “We definitely don’t want this substance to be burned if the risks and precautionary measures are not sufficiently taken into account.” The time window for therapy is very small. People without symptoms who are afraid of dementia are not suitable.
Leqembi makes sense for mild memory disorders
Potential candidates are people with minor impairments, such as mild memory impairments. A reliable detection of Alzheimer’s would be complex, explains Peter Berlit, Secretary General of the German Society for Neurology. This includes a neurological-psychiatric examination, laboratory diagnostics and brain imaging procedures, possibly also a cerebrospinal fluid examination.
However, there is no adequate remuneration for this, says Katharina Bürger. The complex diagnostics alone cost a four-figure sum. In addition, there is therapy and its monitoring. There would be four-figure treatment costs per quarter – plus the cost of the medication. In the USA, therapy with Leqembi costs just under $30,000 a year, the equivalent of around 25,000 euros.
There, the FDA is currently examining the approval of another drug from the same group of active ingredients: Donanemab, an antibody developed by the US pharmaceutical company Eli Lilly, which in studies is said to have slowed mental decline by 35 percent and would therefore be more effective than Lecanemab. It was expected to be approved soon, but the FDA announced last week that the decision would be delayed. (pam)
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