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 and Biogen 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. Biogen’s stock was down more than 5% on Friday morning.
In March 2023, Eisai execs projected $7 billion in worldwide Leqembi sales by 2030.
TD Cowen wrote in a note to investors on Friday, “Although surprised and disappointed, the opinion does not impact our sales estimates of $3.6B by 2028, as we do not currently model sales Ex-US.” Analysts at Jefferies said Friday that at least two-thirds of Leqembi sales estimates are centered on the US, where sales continue “to grow steadily.”
“This is a surprise, given what we heard was a positive political drive to approve an Alzheimer’s drug in EU,” Jefferies said in a note on Friday.
Editor’s note: Article updated with analyst comments on Biogen’s stock price change.