Alzheimer's drug Leqembi launched in first EU markets

Germany and Austria are the first countries in the EU to see the launch of Leqembi, Eisai and Biogen's much-delayed drug for early-stage Alzheimer's disease.

Anti-amyloid antibody Leqembi (lecanemab) made its EU debut in Austria yesterday and will be introduced in Germany on Monday (1st September), becoming the first drug in the class to reach both markets.

Leqembi was finally approved by the European Commission in April, almost 18 months after a marketing application was submitted and after being turned down by the EMA's human medicines committee last summer on the grounds that its modest efficacy was outweighed by potentially serious side effects.

The EU regulator subsequently changed its view and eventually backed approval, albeit with a restricted label, namely patients with a clinical diagnosis of mild cognitive impairment and mild dementia due to Alzheimer's disease who have only one or no copy of the ApoE4 genetic variant.

Patients with only one or no copy of ApoE4 are less likely to experience so-called ARIA side effects, like brain swelling and bleeding, associated with amyloid-targeting drugs, than people with two ApoE4 copies.

Leqembi's launch in Austria and Germany will take place via a controlled access programme that restricts the use and distribution of the drug, allowing access only through a central registration system designed to allow monitoring of patients for side effects.

It could soon be joined in the markets by Eli Lilly's rival anti-amyloid antibody Kisunla (donanemab), which was cleared in July with a similar label restricting its use to patients with one or no ApoE4 genes after an appeal against an earlier rejection.

Eisai and Biogen collaborated on the development of Leqembi, with Eisai taking the lead. They will co-promote the drug in the EU with Eisai in charge of distribution.

"Following the EC approval, Eisai has been collaborating with the regional and local healthcare authorities to implement the mandatory authorisation requirements ahead of launch," said the companies in a statement.

"The required controlled access programme is now in place in Austria and Germany, enabling the launch in these first two EU countries."

Despite being approved in other markets, including the US, since 2023 sales growth for Leqembi has been modest. Latterly, however, it has started to show some glimmers of gathering momentum.

In July, Biogen said that global sales of the drug in the second quarter rose fourfold over the same period of 2024, reaching $160 million, a result that beat analyst expectations and which the company said resulted in part from improved rates of blood tests to diagnose Alzheimer's. The FDA cleared the first blood test to diagnose Alzheimer's in May.