Alzheimer’s drug Leqembi rejected by EU drug regulator

The European Medicine’s Agency (EMA), the drug regulator for the EU, rejected Eisai and Biogen’s Alzheimer’s drug product Leqembi, citing the drug’s slowing of cognitive decline did not outweigh the risk of serious brain swelling. 

Leqembi is currently approved for use in the US, China, Hong Kong, Japan, and South Korea. If it had been approved, it would have been the first drug approved in Europe to treat Alzheimer’s disease, not simply its symptoms. The drug is administered as an infusion twice a month, and operates by removing sticky clumps of amyloid beta protein. This protein is believed to be a hallmark of the neurodegenerative disease and is the target of several clinical drug trials. Leqembi demonstrated a rate of slowing cognitive decline by 27% in early Alzheimer’s patients when compared with a placebo.  

While disappointing those affected by the disease such as the non-profit Alzheimer’s Europe, the EMA have cited their analysis from the Committee for Medicinal Products for Human Use. Three primary reasons stand for the decision. The EMA also pointed to cases of a specific type of brain swelling and bleeding called ARIA, that led to some hospitalisations of patients during the clinical trials.  

Despite disappointment from certain groups, experts state that Leqembi was unlikely to have been widely used in Europe even if it had been approved. In the US, the drug has faced supply chain bottlenecks due to its twice-monthly administration requirements, as well as regular brain scans for patients. These requirements are leading regulators to consider where to shift limited resources including time, money, and trained staff, and what guidance should be created on clinically meaningful benefits in treating Alzheimer’s disease.  

Earlier this year, Eli Lilly’s Alzheimer’s treatment Kisunla received US FDA approval and is currently being reviewed by the EMA as of the publication date of this article. Analysts are sceptical regarding Kisunla’s approval in the EU after the EMA’s rejection of Leqembi. 

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Alzheimer’s drug from Eisai and Biogen rejected in Europe [Accessed July 30, 2024] https://www.reuters.com/business/healthcare-pharmaceuticals/eu-medicines-regulator-rejects-eisai-biogen-alzheimers-drug-2024-07-26/