'New era' in Alzheimer's disease treatment as second drug approved in US

Drug was approved for use by the US Food and Drug Administration this week for patients with mild cognitive impairment or mild dementia stage of disease. File picture

A new treatment for slowing the impact of early Alzheimer’s disease has been approved in the US and welcomed by the Alzheimer Society of Ireland.

This follows earlier American approval of a drug called Lecanemab, which is already under assessment for use in Europe.

The new drug, Kisunla, is also known as donanemab-azbt. 

It slowed cognitive and functional decline by up to 35% compared to the effects of a placebo at 18 months, trials by manufacturer Eli Lilly showed.

Side-effects were also noted, however, including the risk of brain bleeds.

Kisunla targets amyloid plaques in the brain. 

The build-up of these plagues is suspected by many scientists as causing damage leading to Alzheimer’s.

The trials showed an infusion of this treatment once a month for 30 minutes led to a reduction of amyloid plaques on average by 84% compared to at the start of the study.

It was approved for use by the US Food and Drug Administration this week for patients with mild cognitive impairment or mild dementia stage of disease.

Safety warnings are given around the risk of "aria", which the FDA said was “temporary swelling in areas of the brain that usually resolves over time and may be accompanied by small spots of bleeding in or on the surface of the brain”.

Alzheimer Society of Ireland research and policy manager Dr Laura O’Philbin said the FDA decision showed this was “another credible treatment option” for slowing disease progression.

“We have entered a new era in which there are now two treatment options for early Alzheimer’s disease available in the United States,” she said.

However, she cautioned: “These drugs are not cures and they can have serious side-effects.” 

They are only suitable for "a small number of people", she added. 

The drugs cannot yet be used in Ireland as they have not so far been approved by the European Medicines Agency (EMA).

The EMA is expected to decide on Lecanemab by the end of this summer, which means it could reach Irish patients “in the next couple of years”, Dr O'Philbin said.

“Should this happen, significant investment is required to ensure our health system is ready to deliver them,” she added.

“It would be devastating if we had a safe and effective treatment that our health system could not deliver.” 

An estimated 64,000 people live with some form of dementia in Ireland. 

This is expected to more than double by 2045.