14 November 2024: The EMA has today partially approved a marketing application for Leqembi (Biogen/Eisai), having previously rejected it it July 2024, saying that the side effects outweighed the benefits.
“After re-examining its initial opinion, the EMA… has recommended granting marketing authorisation to Leqembi (lecanemab) for treating mild cognitive impairment or mild dementia due to Alzheimer’s disease,” the European Medicines Agency said.
Treatment will only apply to a certain group of patients, those with a lower risk of potential brain bleeding – those who have “only one copy or no copy of ApoE4”, a type of gene known as an important risk factor for Alzheimer’s.
The EMA’s approval will now be sent to the European Commission for a final decision to roll it out on the continent.
