Alzheimer's Drug Leqembi Faces Hurdles in Europe: Concerns Over Health Risks and Healthcare Resources

Experts in Europe considering the potential use of a new Alzheimer's disease drug developed by Eisai Co Ltd ESALY and Biogen Inc BIIB say Leqembi (lecanemab)'s ability to slow cognitive decline may not outweigh its health risks or justify the strain it would place on limited healthcare resources.

The drug is currently undergoing regulatory review in Europe and is likely to receive traditional approval in the U.S. next month after the FDA adcomm unanimously voted to favor the drug.

Treatment with lecanemab reduced clinical decline on the global cognitive and functional scale by 27% at 18 months, relative to the placebo, which is the primary endpoint. That was statistically significant in the analysis of the intent-to-treat population.

European countries prioritize cost-effectiveness when adopting new drugs. Nine neurologists and researchers across six countries have expressed to Reuters that Lecanemab is unlikely to be widely used even if it receives approval, aligning with analyst estimates suggesting that the drug's European market will be relatively small.

There are an estimated 7 million people with Alzheimer's in Europe, a number expected to double by 2030, according to the European Brain Council. 

Some doctors have expressed concerns that the drug's effect on the disease may not be clinically significant enough when weighed against the risk of brain swelling, its expected high price, and the limited personnel and resources required for administering twice-monthly infusions and monitoring for brain swelling using MRI scans. 

In the clinical trial, nearly 13% of patients treated with the drug experienced potentially serious brain swelling.

Barclays analysts predict European sales will gradually increase over time, peaking at around 13% of the patient population in 2032. They forecast sales of $2.6 billion in Europe compared to $3.7 billion in the U.S.

Price Action: BIIB shares are down 0.13% at $313 premarket on the last check Tuesday.

Photo by Gerd Altmann via Pixabay