The European Medicines Agency (EMA) has announced plans to review new safety data concerning Leqembi, a drug designed to treat Alzheimer’s disease. This decision comes in response to the European Commission's request for the Committee for Medicinal Products for Human Use (CHMP) to consider updated safety information prior to granting a marketing authorization. Leqembi is specifically aimed at patients with mild cognitive impairment and early-stage Alzheimer’s disease who carry one or no copies of the apolipoprotein epsilon 4 (APOE4) gene variant.
Leqembi, an amyloid-targeting antibody, focuses on reducing amyloid plaques in the brain, which are believed to play a significant role in the progression of Alzheimer’s disease. The CHMP initially rejected the drug in July 2024 due to concerns that its risks outweighed its benefits. However, after a thorough reexamination of clinical evidence, the committee reversed its stance and recommended granting marketing authorization in November 2024.
The EMA's forthcoming review is crucial, as it will address some of the safety concerns associated with Leqembi. Individuals with two copies of the APOE4 gene variant are at an elevated risk for amyloid-related imaging abnormalities (ARIA), which can manifest in two forms: ARIA-E (edema) and ARIA-H (hemorrhage). These complications can result in severe and symptomatic effects, prompting the CHMP to suggest risk minimization measures to mitigate these risks.
To ensure patient safety, those prescribed Leqembi will undergo continuous monitoring for long-term consequences related to ARIA. The CHMP is set to convene in February to review the new safety data and respond to the European Commission's request. Their findings could significantly impact the future use of Leqembi and its availability to patients suffering from Alzheimer’s disease.
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