European Medicines Agency recommends approval of novel Alzheimer's drug

The European Medicines Agency (EMA) has recommended the drug “Lecanemab” (brand name: Leqembi) for treatment of Alzheimer’s disease. The final decision on a market launch now lies with the EU Commission. The drug has already been approved in the USA, Japan, China, South Korea, the UK and several other countries.

Although the drug cannot cure the disease or stop its development, it can delay its progression. The drug is indicated for people with mild cognitive disorders or in the early stages of Alzheimer's disease. Possible side effects include microbleeding and swelling in the brain. To reduce these risks, the EMA has restricted treatment to patients who carry only one or no copies of a specific gene variant (ApoE4) in their genome.

Unlike conventional Alzheimer's drugs, lecanemab acts on causes by targeting molecular mechanisms and triggers of the disease.  Specifically, it is an engineered antibody that is administered by infusion. The antibody binds to certain proteins (so-called beta-amyloid proteins), which are deposited in the brain in Alzheimer's disease, and helps to break them down.

Prof. Pierluigi Nicotera, Scientific Director and Chairman of DZNE’s Executive Board, comments on the latest development: “DZNE welcomes the EMA’s decision to recommend Leqembi as a disease-modifying treatment for early Alzheimer's disease. This is great news for patients and their families. This could be the beginning of an effective way to slow down dementia and possibly even prevent it in the future. DZNE is actively contributing to this. Not only were DZNE scientists involved in identifying amyloid as a disease-causing agent, they are also developing new tests for the early diagnosis of Alzheimer's disease.”

Alzheimer's researcher Prof. Christian Haass, Speaker for DZNE’s Munich site: “This was about time! This is finally the right decision for patients and their families. The so-called amyloid hypothesis, which has been repeatedly challenged, has been proven correct and has laid the basis for the development of lecanemab and other antibody drugs.”

Prof. Gabor Petzold, Director of Clinical Research at DZNE: “Alzheimer’s is a global pandemic and lecanemab represents a very important step into a new era of getting a better grip on this serious disease. Although the drug cannot cure Alzheimer’s, it can delay its progression. For patients, this means an increase in quality of life. The next step is to apply the drug in standard care, and that is quite challenging. On the one hand, the therapy requires preliminary examinations to identify suitable patients for treatment, and on the other hand, regular follow-up examinations of the brain using magnetic resonance imaging. Specialised clinics and medical centers are generally well equipped for this and will now develop coordinated and responsible treatment structures."

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