Ace Alzheimer Center’s position on the EMA’s positive recommendation on Leqembi (lecanemab)

The EMA has issued a positive opinion on the marketing authorization application for Leqembi (lecanemab) for the treatment of Alzheimer’s disease.

INFORMATIVE NOTE

Barcelona, ​​November 15, 2024

• The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency issued yesterday a positive opinion on the marketing authorization application for the drug Leqembi (lecanemab), developed by the pharmaceutical companies Eisai and Biogen, for the treatment of early-stage Alzheimer's disease.
• Leqembi has already been approved by regulatory authorities in China, Hong Kong, Israel, Japan, South Korea, the United Arab Emirates, the United Kingdom and the United States.

Ace Alzheimer Center Barcelona welcomes the recent approval of Leqembi by the European Medicines Agency (EMA). This drug, designed to treat Alzheimer's disease in its early stages, represents a crucial advance in the treatment of a disease that affects millions of people in Europe and around the world.

The EMA decision marks a before and after: it opens a window of hope for patients and families living with Alzheimer's disease and underscores the value of science and innovation in the search for solutions. It is a step that not only symbolizes progress, but also commitment to improving the quality of life of those who face this reality.

However, it is important to note that this recommendation does not imply that its prescription will be viable in Spain immediately. “For this advance to have a real impact, it is necessary that national health authorities work on the adaptation of Leqembi within the health system, ensuring that patients who meet the criteria for prescribing the drug, can access the treatment as soon as possible and in the safest way,” says Mercè Boada, neurologist, medical director and co-founder of Ace Alzheimer Center Barcelona. The prescription requirements include: a diagnosis of mild cognitive impairment or mild stage dementia, a positive Alzheimer's biomarker, the person does not carry more than one copy of the APOE4 gene, no relevant structural alterations in the brain such as microbleeds, and no treatment with anticoagulants. In addition, it should be remembered that it is a drug that is administered intravenously every 2 weeks, so it requires qualified spaces and trained professionals for its administration.

“This achievement comes after years of research and scientific and healthcare collaboration. We are very proud to have participated in this success through the clinical trial that has made us experts in the management of the drug and has allowed us to be prepared for when we can administer it in Spain,” concludes Miren Jone Gurrutxaga, CEO of Ace Alzheimer Center Barcelona.

At Ace Alzheimer Center Barcelona, we reaffirm our commitment to support patients and their families, promote research and work together with public and private institutions to continue moving towards a future without Alzheimer's disease.

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