Professor of Old Age Psychiatry, UCL Division of Psychiatry, UCL
Less than four months after the European Medicines Agency recommended in July not to grant marketing authorisation for Leqembi™ (lecanemab) for the treatment of Alzheimer's disease, the EMA's Committee for Medicinal Products for Human Use (CHMP) has reassessed the available evidence to conclude that the benefits outweigh the risks.
The European Medicines Agency (EMA) has recommended not granting marketing authorization for Leqembi™ (lecanemab) for the treatment of Alzheimer's disease. The EMA's Committee for Medicinal Products for Human Use (CHMP) considers that its effect in delaying cognitive decline does not outweigh the risk of serious side effects associated with the drug, in particular swelling and possible bleeding in patients' brains. Leqembi™ was approved in 2023 in the United States.
According to a study published today by The BMJ, people with dementia who are treated with antipsychotics are at increased risk of serious adverse events such as stroke, blood clots, myocardial infarction, heart failure, fractures, pneumonia, and acute kidney injury, compared with those who do not take them, . These findings extend the harms previously associated with the use of these drugs on these patients.
A Danish study involving over half a million individuals aged 50 and above, tracked for an average of nearly nine years, reveals that hearing loss is associated with a higher risk of dementia, particularly among those who do not use hearing aids. According to the authors, whose research is published in JAMA Otolaryngology–Head & Neck Surgery, this suggests that hearing aids may prevent or delay the onset and progression of dementia.