EU approves drug for early stage Alzheimerʼs disease

On April 15, the European Commission authorized the use of the drug Leqembi, which is able to combat mild cognitive impairment in the early stage of Alzheimerʼs disease.

Reuters reports this.

The drugs are manufactured by Eisai and Biogen. Leqembi is the first drug approved in the European Union to target one of the key causes of brain pathology. It has been under regulatory review since January 2023.

Leqembi can now be used to treat people who have only one or no copies of the ApoE4 gene and whose brains have been found to have a buildup of the beta-amyloid protein, a hallmark of Alzheimerʼs disease.

In the US, the drug is approved for patients with two copies of the gene, but they must undergo regular MRI scans to monitor brain swelling.

A competing drug from Eli Lilly was rejected in March: it was not effective enough to outweigh serious health risks.

Biogen’s chief development officer, Priya Singhal, said they and partner Eisai are working to make the therapy available to patients in Europe as soon as possible. William Blair analyst Miles Minter predicts that Leqembi will generate more than $900 million in sales by the 2030s.

In addition to the EU, the drug has also been approved in Japan, China, and the United Kingdom.

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