The Alzheimer Society of Ireland Responds to the FDA Full Approval of Lecanemab (Leqembi™)

The Alzheimer Society of Ireland Responds to the FDA Full Approval of Lecanemab (Leqembi™)

The Alzheimer Society of Ireland (The ASI) welcomes the positive decision by the US Food & Drug Administration (FDA) to grant full approval to the Lecanemab antibody, which is marketed as Leqembi, under their traditional approval pathway. Leqembi works with the body’s immune system to target a harmful protein called amyloid beta in the brain, and data indicates that it has the potential to slow down the progression of Alzheimer’s Disease.

There are currently an estimated 64,000 people with dementia in Ireland, and by 2045, that number is anticipated to increase to 150,000.

Responding to this news, The ASI Research and Policy Manager, Dr Laura O’Philbin, said:

“The FDA’s decision to grant full additional approval to the Lecanemab (Leqembi™) antibody is a huge milestone in the race to develop treatment options for Alzheimer’s Disease. This decision means that the FDA feels the drug is safe enough and effective enough to be officially licensed for use across the US. It has been decades since we have seen full traditional FDA approval of any kind of treatment for Alzheimer’s Disease.”

“We will now be looking to the European Medicines Agency, who are conducting their own review of the data. We expect the EMA to make a recommendation to the European Commission on whether Leqembi should be approved for use in Europe late in 2023 or the in first half of 2024. There are no guarantees but we are hopeful that if approved, Leqembi will reach Ireland in the next couple of years. Should this happen, then significant work is required to ensure our health system is ready to deliver it. This work needs to start now. The Alzheimer Society of Ireland looks forward to working with the Government, political representatives, people affected by dementia and clinicians on this matter.”

“If approved, this drug will only be suitable for some people who are in the early stages of Alzheimer’s Disease. There will be many for whom this drug will not be helpful and it is critical that we continue to advocate for and resource non-pharmacological interventions and supports for people with all types of dementia and their families.”

“It is important to remember that this treatment is not a cure and by no means a panacea. However, the research is telling us that it can slow the progression of the disease by removing amyloid from the brain which is incredibly significant. Scientific breakthroughs such as this pave the way for bigger and better treatments, and the future is brighter because of this. The Alzheimer Society of Ireland welcomes this positive news.”