EU Approves Drug for Early-Stage Alzheimer's Treatment

On April 15th, the European Commission granted authorization for the use of Leqembi, a medication capable of combating mild cognitive impairment in the early stages of Alzheimer's disease.

The drug is produced by the pharmaceutical companies Eisai and Biogen. Leqembi stands as the first treatment approved within the European Union that targets one of the fundamental causes of the brain pathology. Regulatory bodies had been reviewing it since January 2023.

Leqembi can now be used for the therapy of individuals who possess either one or no copies of the ApoE4 gene and in whose brains accumulations of the beta-amyloid protein have been detected – a characteristic indicator of Alzheimer's disease development.

In the United States, the drug is approved for patients even with two copies of the gene; however, they are required to undergo regular MRI scans to monitor for brain swelling.

A competing drug from the firm Eli Lilly was rejected in March, as it was deemed insufficiently effective to outweigh significant health risks.

The Head of Development at Biogen, Priya Singhal, stated that together with their partner Eisai, they are striving to make the therapy available to patients in Europe as swiftly as possible. Analyst Miles Minter from William Blair forecasts that Leqembi sales will exceed $900 million in the 2030s.

Beyond the EU, the drug has also received approval in Japan, China, and the United Kingdom.