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 bleeding — those who had “only one copy or no copy of ApoE4”, a type of gene know as an important risk factor for Alzheimer’s.
Such patients are less likely to experience certain serious health problems than people with two copies of the gene, the Amsterdam-based EMA said.
The health problems in question, known as amyloid-related imaging abnormalities (ARIA), include fluid on the brain and brain bleeding.
“The benefits of Leqembi outweigh the risks in patients with mild cognitive impairment or mild dementia due to Alzheimer’s disease with one or no copy of ApoE4.”
This was “provided that risk minimisation measures are in place to reduce the risk of severe and symptomatic ARIA and monitor its consequences in the long term,” it stressed.
Bringing down the risks included providing Leqembi through a “controlled access programme to ensure that the medicine is only used in the recommended patient population” and through MRI scans before and during treatment.
The Amsterdam-based EMA’s approval will now be sent to the European Commission for a final decision to roll it out on the continent.
Pricing and reimbursement will be left up to member states, the EMA said.
Lecanemab has been hailed by Alzheimer’s researchers and charities for being the first approved treatment which tackles the early stages of the disease, rather than managing the symptoms.
It works by using antibodies which bind to and clear the proteins that normally build up in the brains of people with Alzheimer’s, the most common type of dementia.
The treatment has been shown to decrease cognitive decline by a quarter in people in the early stages of the disease.
Britiain’s medicines regulator approved lecanemab in August, making it the country’s first such licensed treatment.
Leqembi, together with another Alzheimer’s drug called Aduhelm, received approval from the US Food and Drug Administration early last year.
