By: Lloyd Mahachi
The European Medicines Agency (EMA) has changed its mind about the Alzheimer’s drug lecanemab, also known as Leqembi. After re-examining the drug, the EMA now recommends approving it for use, but only for certain patients. This decision is a reversal of their initial opinion in July, when they refused to approve the drug due to concerns about its side effects.
Lecanemab is designed to treat mild cognitive impairment and mild dementia caused by Alzheimer’s disease. It works by targeting amyloid beta, a protein that forms plaques in the brains of people with Alzheimer’s. The drug is administered through an infusion once every two weeks. Lecanemab has already been approved in Japan, China, the United States, and Britain.
However, the EMA’s approval comes with some caveats. The drug is only recommended for patients who do not carry the ApoE4 gene, which is associated with an increased risk of Alzheimer’s and also increases the risk of side effects from the drug. The EMA’s human medicines committee considered that the benefits of the drug outweighed the risks for these patients.
The decision is significant, as Alzheimer’s affects an estimated 6.9 million people in Europe, and that number is expected to nearly double by 2050. The drug’s developers, Biogen and Eisai, believe that lecanemab can help slow down the progression of early Alzheimer’s disease and reduce the overall burden on patients and society. The European Commission is expected to make a final decision on the marketing-authorization application within 67 days.
Alzheimer’s is a devastating disease that impacts not only patients but also their families and caregivers. While lecanemab is not a cure, it offers hope for improving the quality of life for those affected. As research continues to advance, we may see more innovative treatments emerge, offering new possibilities for managing and potentially preventing this debilitating disease.
Editor: Josephine Mahachi
