Europe’s medicines watchdog on Thursday partially approved a marketing request for a long-awaited new treatment for Alzheimer’s disease, reversing an earlier decision not to give it the green light.
“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, adding treatment would only apply to a certain group of patients.
Leqembi, developed by US multinational Biogen and Japanese-based Eisai, is the brand name of an active substance called lecanemab that is used to treat adults with mild memory and cognitive problems resulting from the early stages of the common type of dementia.
The EMA in July rejected a marketing request, saying the side effects, including potential brain bleeding, outweighed the benefits.
The EMA now endorsed the treatment, but only for patients with a lower risk of potential brain …