A licence for an Alzheimer’s medication that reduces cognitive decline has been denied by the European Medicines Agency (EMA).

According to the EMA, lecanemab’s advantages did not outweigh the possibility of major adverse effects, such as brain swelling and haemorrhage.

A decision about the granting of a licence is still pending from the UK’s pharmaceuticals authority, the MHRA. The medication received US approval earlier this year.

Lecanemab has been demonstrated in studies to reduce cognitive deterioration in people with early-stage Alzheimer’s disease by around 25%.

Because no other medication had demonstrated that the basic process of the illness might be delayed, Alzheimer’s researchers praised the study results as “historic”.

Lecanemab acts by removing amyloid, a renegade protein that accumulates in the brains of people suffering from Alzheimer’s disease.

The decision as to whether the medication is cost-effective and ought to be prescribed to patients rests on health organisations like the Scottish Medicines Consortium (SMC) and the National Institute for Health and Care Excellence (NICE).

In the United States, lecanemab costs around £20,000 per patient annually.

Lecanemab, a drug sold under the trade name Leqembi, was shown to have modestly slowed cognitive deterioration in patients, according to the EMA.

The frequent incidence of amyloid-related imaging abnormalities (ARIA), which include brain haemorrhage and oedema, was cited as the primary safety issue.

“Although the majority of ARIA cases in the main study were not serious and did not involve symptoms, some patients experienced serious events, including large brain bleeds that required hospitalisation,” the European Medicines Agency (EMA) stated.

Overall, the results showed that the dangers did not outweigh the advantages of the therapy.

The British Neuroscience Association’s president, Prof. Tara Spires-Jones, expressed dismay with the EMA’s decision, calling it “a disappointment to many”.

She did, however, add that there were causes for optimism.

“Research does work, as demonstrated by lecanemab’s ability to delay the course of illness. Prof. Spires-Jones stated, “At this point, we must intensify our efforts to find better and safer therapies.

Prof John Hardy, professor of neuroscience and group leader at the UK Institute for Dementia Research, University College London (UCL), said the decision could have unintended consequences.

“I am sure we will now see rich people with early Alzheimer’s disease flying to the US or other jurisdictions for treatment.”

The BBC’s Panorama program tracked patients receiving lecanemab and donanemab, two novel medications.

Prof. Cath Mummery, a consultant neurologist and head of clinical trials at the Dementia Research Centre at UCL, stated in the documentary that although the advantages of the medications were modest, they marked a “turning point.” The episode aired earlier this year.

“I don’t think they’re a false hope,” she continued. It’s remarkable that for the first time, medications are available that demonstrate the ability to change the trajectory of Alzheimer’s disease.

Although it respects the company’s decision, the Alzheimer’s Society stated that this would be “very difficult news for people in Europe who may have been eligible for this drug.”

“Whatever the regulators decide, we remain at an important and exciting moment,” said Mark MacDonald, from the society.

“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.”

(Adapted from BBC.com)