Europe’s drug watchdog on Thursday partially approved the 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 the granting of marketing authorization to Lekambi (lecanmab) for the treatment of mild cognitive impairment or mild dementia due to Alzheimer’s disease,” the European Medicines Agency said. A certain group of patients.
Lechembi, developed by the American multinational Biogen and Japanese-based Eisai, is the brand name of an active substance called lecanmab that is used to treat adults with mild memory and cognitive problems resulting from the early stages of common types of dementia.
The EMA rejected a marketing request in July, saying the side effects, including possible brain bleeding, outweighed the benefits.
The EMA has now endorsed the treatment, but only for patients at low risk of potential brain bleeding – those who have “only one copy or no copies of APOE4”, a type of gene thought to be a significant risk factor for Alzheimer’s. Known as.
The Amsterdam-based EMA said such patients are less likely to experience some serious health problems than people with two copies of the gene.
The health problems in question, known as amyloid-associated imaging abnormalities (ARIA), include fluid on the brain and brain hemorrhage.
“The benefits of Lecambi outweigh the risks in patients with mild cognitive impairment or mild dementia due to Alzheimer’s disease with one or no copies of ApoE4.”
This is “provided that risk reduction measures are in place to reduce the risk of severe and symptomatic ARIA and to monitor its consequences in the long term,” it stressed.
Minimizing the risks includes “providing Lecambi through a controlled access program 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 the final decision on its implementation on the continent.
Pricing and reimbursement will be left to member states, the EMA said.
Lecanumab has been praised by Alzheimer’s researchers and charities as the first approved treatment that tackles the early stages of the disease rather than managing symptoms.
It works by using antibodies that bind and clear proteins normally made in the brains of people with Alzheimer’s, the most common type of dementia.
The treatment has been shown to reduce cognitive decline by a quarter in people in the early stages of the disease.
Britain’s drug regulator approved lecanmab in August, making it the first such licensed treatment in the country.
Lecambi received approval from the U.S. Food and Drug Administration early last year along with another Alzheimer’s drug, Aduhelm.
(Except for the headline, this story has not been edited by NDTV staff and is published from a syndicated feed.)
