The Alzheimer’s Drug Leqembi Sparks Optimism

The drug has been on the US market since last year.  Michael Clevenger/CourierJournal/Imago

The drug has been on the US market since last year. Michael Clevenger/CourierJournal/Imago © IMAGO/USA TODAY Network

The European Medicines Agency is checking whether Lekembi will also be approved in the EU after the US. But the drug works only in mild memory disorders.

Frankfurt – The antibody lecanemab can reduce the formation of amyloid beta protein plaques in the brain and slow the progression of Alzheimer’s dementia if given at a very early stage. In the USA, the FDA approved the drug under the brand name Leqembi last year. The experts there spoke about an important event. It was developed by pharmaceutical companies Eisai (Japan) and Biogen (USA).

The European Medicines Agency Ema is currently studying EU approval. The decision is expected in the first semester, possibly even in the next few days. The committee responsible for human medicine must weigh whether the clinical benefit for a 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 reach the EU market, it would be the first drug to address the fundamental mechanisms of Alzheimer’s disease. However, it cannot achieve a cure. The condition is still getting worse, just slower.

Lecanemab is an active ingredient from the group of monoclonal antibodies. These are proteins that target a specific structure, in this case amyloid beta protein. It is considered one of the “major players” in Alzheimer’s disease by building up plaques 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 why Lecanemab is only suitable for early-stage patients.

Alzheimer’s disease is usually only recognized when the damage is advanced

The main problem here is that the disease is usually only recognized when the brain damage is already well advanced. Developing simple, reliable tests is as important as treatment methods. So far, there is only one safe blood biomarker, and a suitable test could be on the market in the next few years.

In a phase 3 study involving 1,795 participants, lecanemab delayed disease progression by 27 percent. Brain swelling occurred in 17 percent of subjects taking it, but in most cases it was asymptomatic. Experts emphasize that strict monitoring is still necessary. This also applies to microbleeds in the brain that may occur during therapy.

Therefore, treatment is contraindicated or should be considered very carefully in people who have an increased risk of bleeding (including through medication) and risk of stroke. The medication is given as an infusion every two weeks, each one hour long. In the US, this happens in doctors’ offices or special infusion centers.

Anti-Alzheimer drug Lekambi. the expert warns about “false hopes”.

One of the biggest challenges after potential approval will be filtering out 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 figure at about 20,000 in Germany during a discussion at the Science Media Center. He suspects the number of people who want the drug is likely to be much higher.

This assessment is shared by Frank Jessen, head of the Clinical Alzheimer’s Research Working Group at the German Center for Neurodegenerative Diseases. Some patients have already applied as self-payers or even traveled to the US to receive infusions there.

For Germany, Katharina Burger calls for careful choices and warns against “false hopes”. “We definitely don’t want this material to burn unless the risks and precautions are adequately taken into account.” The time window for therapy is very small. People without symptoms who fear dementia are not suitable.

Leqembi is meaningful for mild memory disorders

Potential candidates are people with mild impairments, such as mild memory impairments. Reliable detection of Alzheimer’s will be difficult, explains Peter Berlitt, Secretary General of the German Society of Neurology. This includes neurological-psychiatric examination, laboratory diagnosis and brain imaging procedures, possibly also examination of cerebrospinal fluid.

However, there is no corresponding remuneration for this, says Katharina Burger. Complex diagnostics alone cost four-figure sums. In addition, there is therapy and its monitoring. There will be four-figure quarterly treatment costs plus the cost of medication. In the US, Leqembi therapy costs just under $30,000 a year, which is equivalent to around €25,000.

There, the FDA is currently reviewing the approval of another drug with the same active ingredients, Donanemab, an antibody developed by the US pharmaceutical company Eli Lilly that studies have shown to slow mental decline by 35 percent and thus may 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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