Regulatory authorities in the European Union have declined to approve Eisai and Biogen’s Leqembi treatment for the early stages of Alzheimer’s because the danger of serious brain swelling does not justify the modest effect it has on slowing down cognitive deterioration.
This is a setback for the companies as the drug experiences slow adoption in the US, even as it addresses the challenges associated with a new class of drugs that have been a game-changer for early-phase patients but come with infrequent but serious side effects.
The therapy is authorized in the United States, China, Hong Kong, Israel, Japan, and South Korea. It would have been the first drug in Europe to treat neurodegenerative disease rather than just the symptoms. The drug, known chemically as lecanemab, is administered via infusion once every two weeks and helps eliminate the aggregation of amyloid beta protein from the brain, which scientists consider a hallmark of Alzheimer’s disease.
Although the drug has not been approved by the US Food and Drug Administration as an Alzheimer’s treatment, it has been shown to slow cognitive deterioration by up to 27% compared to a placebo in early diagnosis Alzheimer’s patients in clinical trials.
While seven million people in Europe currently suffer from the disease, this number is expected to reach fourteen million by 2050, according to Alzheimer’s Europe, a non-profit organization that expressed its disappointment regarding the recent decision.
The Committee for Medicinal Products for Human Use provided recommendations that the EU regulator used as a basis for its decision. The committee gave three main justifications for the rejection. First, an 18-point scale used in the trial to measure functions such as memory and problem-solving showed that the absolute difference between patients treated with lecanemab and those given a placebo was small. Second, the study found an increased risk of brain edema and hemorrhage in patients with a double dose of the APOE4 gene, which increases the risk of Alzheimer’s.
