Revolution in Alzheimer's therapy: Leqembi starts on September 1st!

Revolution in Alzheimer's therapy: Leqembi starts on September 1st!

A new glimmer of hope in Alzheimer's treatment is in the starting blocks: the Alzheimer's drug Leqembi (active ingredient: lecanemab) will be available in Germany from September 1, 2025. This reports Daily Mirror. The active ingredient aims to reduce harmful protein deposits in the brain known as amyloid-β plaques. A key goal of therapy is to halt the progression of Alzheimer's dementia rather than simply alleviating the symptoms.

However, the approvals for Leqembi were not without controversy. While the US Food and Drug Administration (FDA) gave the drug the green card in January 2023, the European regulatory authority (EMA) initially hesitated due to possible serious side effects known as ARIA (amyloid-relative imaging abnormality). But in April 2025 the tide turned: the European Commission granted approval on the recommendation of the EMA, and the market launch in Germany and Austria is now a fact. This represents a significant step forward in the treatment of early Alzheimer's disease.

Who can be treated?

As tagesspiegel.de highlights, around 73,000 potential patients in Germany are suitable for therapy with lecanemab. An important point is still early diagnosis, which requires complex neuropsychological tests, MRI scans and even cerebrospinal fluid examinations. Registration in a central patient register will also be necessary to determine suitability for the drug. However, there are some exclusion criteria, such as serious vascular diseases in the brain or taking oral anticoagulants, which can influence the treatment options.

Lecanemab infusion therapy is given every 14 days for up to 18 months. This poses new challenges for outpatient practices and hospitals, as the preparation of the outpatient clinics for market launch is already in full swing in order to care for patients from September.

Efficacy and safety in focus

Lecanemab is a groundbreaking development, but the road to practice could be rocky. In clinical trials, it has been shown that the difference in cognitive improvement compared to placebo groups was often marginal. In fact, the administration of the drug also raises concerns about side effects, which can affect a significant proportion of patients. 45% of participants reported treatment-related side effects, from severe brain swelling to bleeding. The risks of therapy have been regularly questioned by doctors and scientists and it remains to be seen how the therapy landscape will develop, in which hardly any new drugs have come onto the market since 2003 despite significant investments in Alzheimer's research.

Cheers to research: The drug Leqembi gives hope to many who suffer from Alzheimer's. But before it can be used widely and safely, it still requires a lot of commitment from doctors, patients and regulators. How alz.org As explained, the participation of everyone involved in the exchange of information is crucial in order to achieve the best possible treatment results.

For all those affected and their relatives, it is important to get involved now and get advice. Because despite all the challenges, there is hope for a better life with Alzheimer's.