The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has approved a product license for Eisai and Biogen’s lecanemab (Leqembi) to treat adult patients in the early stages of Alzheimer’s disease (AD) in Great Britain.
Lecanemab is the first Alzheimer’s disease treatment licensed in Great Britain that demonstrates some evidence of effectiveness in slowing the disease’s progression.
The decision was based on expert scientific guidance from the Commission on Human Medicines (CHM), the government’s independent advisory body.
Leqembi is now approved for treating adults in the early stages of AD who have either one or no copies of the apolipoprotein E4 gene (ApoE4).
The drug also becomes the first treatment for early AD to be authorised in a country in Europe.
The approval was primarily based on Phase 3 data from Eisai’s global placebo-controlled, double-blind, parallel-group, randomised Clarity AD clinical trial.
In the trial, the monoclonal antibody met its primary endpoint of change from baseline in the Clinical Dementia Rating Sum of Boxes (CDR-SB) at 18 months.
It also achieved statistically significant results for all key secondary endpoints.
MHRA healthcare quality and access interim executive director Julian Beach said: “We’re assured that, together with the conditions of the licence approval, the appropriate regulatory standards for this medicine have been met.
“As with all medical products, we will keep its safety under close review, and with a controlled post-authorisation safety study to be undertaken, we will ensure that the benefit risk of lecanemab in clinical use is closely followed up.”
The MHRA will monitor the safety and effectiveness of lecanemab. To ensure its safe and effective use, and to closely review its safety and efficacy, a central registration system will be used for the initiation of treatment under a controlled access programme.
Additionally, a controlled post-authorisation safety study will be conducted to assess the drug’s safety and benefit-risk profile in routine clinical practice.
The study will focus on the incidence and severity of ARIAs and intracerebral hemorrhage, as well as the long-term safety of the treatment.
In Great Britain, Eisai and Biogen will co-promote the medicine, with Eisai serving as the Marketing Authorisation holder and responsible for distribution.
In May this year, the Ministry of Food and Drug Safety (MFDS) in South Korea approved Leqembi for AD treatment.
