EMA does not recommend Leqembi for the treatment of Alzheimer’s disease

 

 

 BtoBio Innovation

Btobioinnovation.com 

Author: Jean-Claude Muller, 穆卓Executive Editor at BtoBioInnovation  jcm9144@gmail.com

 

 

SPECIAL REPORT 24.07

 

EMA does not recommend Leqembi for the treatment of Alzheimer’s disease

 

On July 25, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommended against marketing authorisation of BioArtic, Eisai and Biogen’s Lequembi, or lecanemab, an amyloid antibody for the treatment ofAlzheimer’s disease.

The committee considered that “the observed effect of Leqembi on delaying cognitive decline did not counterbalance the risk of serious side events associated with the medicine, in particular the frequent occurrence of amyloid-related imaging abnormalities (ARIA), involving swelling and potential bleedings in the brain of patients who received Leqembi.

The decision does not come as a full surprise to some of the observers. The fact sheet delivered by the EMA stated:

“The main study showed that after 18 months of treatment, the Clinical Dementia Rating Scale Sum of Boxes score (CDR-SB) —an index used to measure dementia severity—in patients treated with Leqembi increased by 1.21 compared with 1.66 in patients who received placebo. The most important safety concern with Leqembi is the frequent occurrence of amyloid-related imaging abnormalities (ARIA), a side effect, seen in brain imaging, that involves swelling and potential bleedings in the brain. Although most cases of ARIA in the main study were not serious and did not involve symptoms, some patients had serious events, including large bleeds in the brain which required hospitalisation. The seriousness of this side effect should be considered in the context of the small effect seen with the medicine.  In addition, the CHMP was concerned by the fact that the risk of ARIA is more pronounced in people who have a certain form of the gene for the protein apolipoprotein E called ApoE4. The risk is highest in people with 2 copies of the ApoE4 gene, who are known to be at risk of developing Alzheimer’s disease and would therefore be likely to become eligible for treatment with Leqembi.”

Leqembi is already approved in the U.S., Japan, China, South Korea and Israel. The fact that Leqembi decreased the amount of beta-amyloid, an important surrogate factor for Alzheimer’s disease, did not get a similar attention by the EMA and the FDA.

“We are surprised and very disappointed by the CHMP’s opinion posted today,” BioArctic CEO Gunilla Osswald said in an emailed statement who stressed that… “this is not the final verdict.”

In a Friday note to clients, Mizuho Securities said it figured the news was "more of a delay in the Leqembi European application" rather than an outright rejection.

It is now noteworthy to follow the handling of Eli Lilly’s aducanumab, another beta amyloid antibody already approved by the FDA, by the EMA.

Paris, July 28, 2024.

 

This document has been prepared by btobioinnovation and is provided to you for information purposes only.  The information contained in this document has been obtained from sources that btobioinnovation believes are reliable but btobioinnovation does not warrant that it is accurate or complete. The views presented in this document are those of btobioinnovation’s editor at the time of writing and are subject to change.  btobioinnovation has no obligation to update its opinions or the information in this document.

 

 

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