Thumbs down for lecanemab in the EU – “Very surprised”
Lecanemab has been approved in the US, Japan, China, South Korea, Hong Kong and Israel for treating early Alzheimer’s. Developed by Swedish Bioarctic in collaboration with Japanese Eisai, the Alzheimer’s drug is an antibody targeting soluble and insoluble aggregated forms of amyloid beta.
In Europe, a decision from the CHMP, which issues recommendations for market authorisation, was delayed until last week when lecanemab was given a negative assessment.
According to a meeting summary, the Committee does not recommend marketing authorisation of the drug as it does not find that its observed efficacy outweighs the side effects lecanemab may cause.
In particular, the committee points to the number of patients affected by so-called ARIA, which is swelling and potential bleeding in the brain.
“I am very surprised! If you look at our data, we have very robust data showing a clear effect on both primary and all secondary endpoints,” says Gunilla Osswald to Life Science Sweden.
“It has clear clinically meaningful effects. Yes, it has side effects, just like any other drug, so monitoring is important, especially in the first six months, to ensure that the risk is minimised. However, from what I have been hearing from doctors, the vast majority of them think that this can be managed.”
In the phase 3 study of lecanemab, presented in 2022, there was a 27% reduction in deterioration in those receiving treatment compared to placebo.
When we speak to Gunilla Osswald by phone, she is in Philadelphia, USA, at the Alzheimer’s Association International Conference (AAIC), which brings together researchers and clinicians in the field.
“The reaction from the vast majority of participants is one of astonishment and shock.”
On Wednesday, the company’s partner, Eisai, presented new long-term data at the congress. According to the company’s data, treatment with lecanemab continues to provide increasing benefits for patients with Alzheimer’s after three years of ongoing treatment with the drug. Data from the earliest patient group were also presented, with 51% of patients still showing improvement in cognition and function after three years, Bioarctic said in a press release.
Soon after last week’s CHMP decision, Bioarctic announced that its partner, Eisai, will apply for a re-examination.
“This process will probably take about four months. We expect a new decision before the end of the year, and we truly hope that the decision will be favourable for all European patients,” says Gunilla Osswald.
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