Alzheimer’s Drug Rejection by EMA

As per Technology Networks report “European Medicines Agency (EMA) committee has recommended the refusal of EU marketing authorization for Alzheimer’s drug lecanemab (Leqembi), which was only last year given the green light for approval by the US Food and Drug Administration (FDA)”.

Leqembi (commercial name for lecanemab) is an investigational monoclonal antibody developed for treating Alzheimer’s disease. It targets protofibrils of amyloid-beta, a protein that accumulates abnormally in the brains of individuals with Alzheimer’s, forming plaques that are believed to contribute to neurodegeneration. Leqembi works by binding to these protofibrils and facilitating their clearance from the brain, potentially slowing the disease’s progression. Clinical trials have been conducted to evaluate the efficacy and safety of Leqembi in patients with early Alzheimer’s disease, with some promising results showing a reduction in amyloid plaques and a slower cognitive decline compared to placebo. However, as with many experimental treatments, the safety profile and long-term effects of Leqembi are subjects of ongoing research and debate within the medical community. The therapeutic landscape for Alzheimer’s disease remains one of high interest, given the significant unmet need for effective treatments, and Leqembi represents a beacon of hope for advancing the care and management of this debilitating condition.

The news concluded that “The EMA’s decision will come as a disappointment to many, but there are reasons to remain hopeful. Lecanemab has shown that it is possible to slow down disease progression, and research does work,” said Prof. Tara Spires-Jones, president of the British Neuroscience Association and director of the Centre for Brain Science Discovery at the University of Edinburgh. “Each discovery brings us closer to new and better treatments.” The full article can be seen with title “New Alzheimer’s Drug Rejected by European Medicines Agency Committee”.