Dementia Support Line
EU’s rejection of the Alzheimer's disease drug lecanemab
The European Union’s drugs regulator, the Committee for Medicinal Products for Human Use (CHMP), has advised that the drug lecanemab, a treatment for Alzheimer’s disease, should not be approved for use in the EU.
Alzheimer’s Society funded research 30 years ago which identified the role of the amyloid plaques targeted by lecanemab in Alzheimer’s disease.
Mark MacDonald, Associate Director of Evidence, Policy and Influencing at Alzheimer’s Society, said:
"We’re disappointed that lecanemab has not met the safety and effectiveness requirements to be licensed in Europe. While we fully respect the decision, we acknowledge it will be really difficult news for people in Europe who may have been eligible for this drug.
“Here in the UK, Alzheimer’s Society awaits decisions from the MHRA and NICE on both lecanemab and donanemab as regulators scrutinise the evidence around these treatments.
“Whatever the regulators decide, we remain at an important and exciting moment. There are currently 164 active clinical trials for Alzheimer’s disease and we expect more treatments to be submitted for MHRA approval in the future. We are on the cusp of major scientific breakthroughs beginning to improve the outlook for those with the disease.
“That makes it even more important that we improve diagnosis. A third of people in the UK with dementia don’t have a diagnosis at all, let alone one with the timeliness and accuracy required to unlock access to the new treatments on the horizon.
“New, ambitious dementia diagnosis rate targets should be set, accompanied by funded plans to deliver early, accurate diagnosis at scale."
