Alzheimer’s, EMA blocks drug Lecanemab: here’s why

European Medicines Agency EMA says no to anti-Alzheimer’s therapy. The Technical Committee for Medicinal Products for Human Use of the EU regulatory body, “CHMP, has recommended not to grant a marketing authorisation for Leqembi* (lecanemab), a medicine intended for the treatment of Alzheimer’s disease”, informs the EMA in the report of the latest CHMP meeting (22-25 July).

“The Committee – it reads – considered that the observed effect of Leqembi on delaying cognitive decline does not outweigh the risk of serious side effects associated with the medicine, in particular the frequent occurrence of amyloid-related (Aria) imaging abnormalities, which lead to swelling and potential bleeding in the brains of patients who received Leqembi”.

Alzheimer Europe expresses “regret” and “deep disappointment” for the negative opinion formulated by the Technical Committee CHMP of the European Medicines Agency EMA. The EMA’s no, which concerns the EU, Iceland, Liechtenstein and Norway, the association underlines in a note, “means that Europeans with early-stage Alzheimer’s disease will not have access to the therapeutic options available to patients in the United States and other countries”.

“People living with Alzheimer’s disease and their families have had great hopes and expectations regarding the introduction of new treatment options in Europe,” writes Alzheimer Europe, recalling that the US FDA granted approval to lecanemab a year ago, in July 2023, after an advisory committee unanimously recognized the clinical efficacy of the drug for which the main US insurance companies, including Medicare, have guaranteed “broad coverage” in patients eligible to receive it. Regulatory authorities in Japan (September 25, 2023), China (January 3), South Korea (May 27), Hong Kong (July 11) and Israel (July 12) have also given the green light to the treatment, the association lists, while in Europe the pronouncements of the Swiss and British regulatory bodies are still awaited, which Alzheimer Europe hopes will be positive.

“People with Alzheimer’s disease in Europe will be excluded from access to lecanemab without being able to make individual choices based on a personal risk-benefit analysis,” the association notes. Alzheimer Europe hopes that “real-world results from the FDA-mandated registry or ongoing studies on lecanemab will provide the scientific evidence needed for EU regulators to reconsider their position.”