European Medicines Regulator Rejects New Alzheimer’s Drug

Europe’s medicines regulator has rejected a marketing request for a new Alzheimer’s disease treatment, saying the risks of the medicine’s side effects.

The medicines regulator in the UK, the MHRA, is still considering whether to grant a licence, and a decision is expected soon. The drug was approved in the United States earlier this year.

Lecanemab, which targets the amyloid in the brain that are one of the main characteristics of Alzheimer’s disease, also carries a risk of serious side effects including brain bleeds and swelling.

The Committee, which is made up of scientific experts from all EU member states, ruled that the ‘’effect of Leqembi on delaying cognitive decline does not counterbalance the risk of serious side effects associated with the medicine.’’

In other words, the committee does not think the benefits of taking the drug outweigh the risks due to side effects.

Alzheimer’s researchers hailed the trial results as “historic” because no previous drug had convincingly shown that the underlying mechanism of the disease could be slowed.

The committee’s recommendation will now go on to be considered by the European Commission, an arm of the European Union, who will make a final decision as to whether to grant the drug a license for the EU.

The first step in the EMA’s decision-making process is taken by a body called The Committee for Medicinal Products for Human Use (CHMP) – the EMA’s committee responsible for assessing medicines.

The significance of today’s decision is reinforced by the fact that the European Commission follows the opinion of the CHMP in “almost all cases”, according to the EMA’s website.

“Lecanemab is not a cure for Alzheimer’s disease,” said Prof Jonathan Schott, Chief Medical Officer at Alzheimer’s Research UK “but evidence from clinical trials suggests that it can slow progression in people with mild forms of the disease, in whom it leads to benefits in quality of life and reduces impact on carers.”

“While it is of course vital to balance benefits and potentially serious side-effects, the EMA’s recommendation runs counter to the decision reached by other G7 nations like the US and Japan, whose regulators have already given the green light to this drug and have embedded risk management plans to address potential side effects.”

“Attention will now turn to the UK’s regulator – the MHRA – which is expected to announce a decision on lecanemab imminently. This announcement can’t come too soon for people with Alzheimer’s disease in Great Britain who for now must wait while other countries forge ahead with innovative medicines.”

The UK’s largest dementia charity, Alzheimer’s Society, which funded research 30 years ago responsible for identifying the role of the amyloid plaques targeted by lecanemab in Alzheimer’s disease, responds to the news.   

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.”