EMA's medicines committee (CHMP) has recommended not granting marketing authorization for the Eisai-Biogen partnered Alzheimer's treatment, Leqembi.
According to the EMA, the committee found that the observed effect of Leqembi on delaying cognitive decline does not counterbalance the risk of serious side events associated with the medicine — in particular the frequent occurrence of amyloid-related imaging abnormalities (ARIA), involving swelling and potential bleedings in the brain of patients who received Leqembi.
CHMP also noted concern that the risk of ARIA is more pronounced in people who have a specific form of the gene for the protein apolipoprotein E, known as ApoE4. According to the committee, "the risk is highest in people with 2 copies of the ApoE4 gene, who are known to be at risk of developing Alzheimer’s disease and would therefore be likely to become eligible for treatment with Leqembi."
Leqembi was granted U.S. approval in January 2023 for the treatment of mild cognitive impairment due to early-stage Alzheimer’s disease through the FDA's accelerated approval pathway. In July 2023, the FDA officially changed the approval status from accelerated approval to traditional approval. The approval came with a black boxed warning due to the ARIA safety concerns. Leqembi also has approval in Japan, China, South Korea, Hong Kong and Israel.
Eisai noted in a press release that the company is "extremely disappointed" by the decision and that it will seek re-examination of the CHMP opinion and work with the relevant authorities to bring Leqembi to the EU.
