CHICAGO, November 14, 2024 — The Alzheimer’s Association welcomes today’s decision by the European Medicines Agency (EMA) to recommend the approval of Leqembi® (lecanemab) for marketing in Europe. Today’s action is a reversal of the agency’s negative July decision.
“This is an important step toward Europeans having access to a proven treatment that changes the underlying course of Alzheimer’s. While not a cure, this treatment can slow progression of the disease when taken in the early stages of Alzheimer’s, allowing people more time to participate in daily life and live independently. We appreciate the EMA’s fast review and reversal of its earlier decision,” said Joanne Pike, DrPH, Alzheimer’s Association president and CEO.
In issuing its revised decision, the EMA’s human medicines committee (CHMP), determined that in a more restricted population — patients with only one or no copy of ApoE4 — “the benefits of Leqembi in slowing down progression of symptoms of the disease are greater than its risks.” The Alzheimer’s Association disagrees with the decision to exclude this patient population from the eligible treatment pool and encourages the EMA to continue to review clinical trials and real world evidence and expand their recommendation. Following today’s decision, the European Commission is now expected to make a final recommendation on the application to market Leqembi across the European Union.
Because Leqembi is indicated for people with early Alzheimer’s, early detection and diagnosis are critical to ensure individuals are eligible for treatment, and receive the most benefit at the earliest point possible. It is more important than ever that patients and their families have informed discussions with their health care providers about the potential risks and benefits of treatments.
About the Alzheimer's Association
The Alzheimer’s Association is a worldwide voluntary health organization dedicated to Alzheimer’s care, support and research. Our mission is to lead the way to end Alzheimer's and all other dementia — by accelerating global research, driving risk reduction and early detection, and maximizing quality care and support. Our vision is a world without Alzheimer's and all other dementia®. Visit alz.org or call 800.272.3900.