Regulators Reevaluate Lecanemab
European regulators have shifted their stance on the Alzheimer’s drug lecanemab, recommending it for marketing authorization after previously expressing concerns about its safety. In July, the European Medicines Agency (EMA) concluded that the drug’s risks overshadowed its potential benefits, but recent evaluations prompted a change in direction.
What Is Lecanemab?
Lecanemab, marketed as Leqembi, is administered via an intravenous drip every two weeks. This drug targets amyloid beta, a protein component responsible for the formation of troublesome plaques in the brains of individuals with Alzheimer’s. The disease, a leading cause of dementia, currently affects an estimated 7.8 million people across the European Union.
Clinical Trial Success
In clinical trials, Leqembi demonstrated the ability to slow cognitive decline associated with Alzheimer’s disease. However, EMA regulators had emphasized the significant risks, such as brain swelling and potential bleeding, especially in patients who receive the treatment. Initially, they ruled that these dangers outweighed the benefits.
Controlled Access for Patients
The EMA has stipulated that Leqembi will only be available through a controlled access program, specifically targeting patients with one or no copies of the ApoE4 gene, a known risk factor for Alzheimer’s. Those lacking this gene or possessing just one copy face a lower risk of adverse side effects. The program ensures that patients are closely monitored for serious complications using brain scans.
Global Approval and Controversy
While U.S. regulators approved Leqembi in 2023 and the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) followed suit in August, the drug has yet to be made available on the UK’s National Health Service (NHS). The NHS determined that the benefits derived from Leqembi were insufficient to justify its costs, highlighting the ongoing debate surrounding the treatment’s value amidst its potential risks.
SOURCE: Ref Image from Times Of India
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