The European Medicines Agency on Friday held its ground against anti-amyloid treatments, saying it will not recommend Eisai and Biogen’s Alzheimer’s drug Leqembi for approval.
The decision, according to the EMA’s medicines committee (CHMP), is due to only a slight advantage of Leqembi over placebo on a clinical dementia rating scale, and the potential for serious side effects. CHMP previously rejected Biogen’s other Alzheimer’s drug Aduhelm, and is still reviewing Eli Lilly’s donanemab. Leqembi, Aduhelm and donanemab are now approved in the US.
CHMP said that it “considered that the observed effect of Leqembi on delaying cognitive decline does not counterbalance the risk of serious adverse events associated with the medicine.”
Amyloid-related imaging abnormalities (ARIA) are a side effect of Leqembi that can cause brain swelling and potential bleeding and was cited by CHMP as a main concern.
“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,” CHMP said.
The medicines committee also said it was concerned that ARIA risks are more pronounced in those with a form of the gene for the protein known as ApoE4.
Eisai said in a statement that it will seek re-examination of the CHMP opinion and work with the relevant authorities to ensure Leqembi is available in the EU.
Eisai execs in March 2023 projected $7 billion in worldwide Leqembi sales by 2030. Analysts at Jefferies previously projected in March about $19 million in EU sales of Leqembi in 2025.