Approval for Lecanemab (marketed as Leqembi®) has hit a roadblock in Europe. According to drug developers Eisai and Biogen, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a negative opinion on the marketing authorization approval for the drug.
In response, Eisai said that they will seek re-examination of the CHMP opinion and work with the relevant authorities to ensure that the treatment is available for eligible patients in the EU as soon as possible. “We are extremely disappointed by the CHMP’s negative opinion and understand that this may also be disappointing for the wider Alzheimer’s disease community,” Lynn Kramer, MD, Eisai’s chief clinical officer, said in a statement. “There is a significant unmet need for new innovative treatment options that target an underlying cause of disease progression. We remain focused on making a meaningful difference to those living with early AD and those closest to them.”
Lecanemab is a humanized anti-soluble aggregated amyloid-beta monoclonal antibody for treating mild cognitive impairment due to Alzheimer’s disease (AD) and mild AD. The drug has been approved in the United States, Japan, China, South Korea, Hong Kong, and Israel based on Phase III data from Eisai’s global Clarity AD clinical trial.
In that trial, treatment with Lecanemab reduced clinical decline on CDR-SB by 27% at 18 months compared to placebo. It is currently being marketed in the United States, Japan, and China. Eisai serves as the lead for lecanemab’s development and regulatory submissions globally with both Eisai and Biogen co-commercializing and co-promoting the product and Eisai having final decision-making authority. They have been collaborating on the development and commercialization of AD treatments since 2014.
According to Biogen’s Q1 2024 results, Leqembi recorded global in-market sales of approximately $19 million, nearly double the $10 million generated in 2023. They also reported that the number of patients on therapy increased nearly 2.5 times since 2023.
