Disease Modifying Therapies Updates
Last updated 22/04/2025
On 15th April, the European Commission granted EU authorisation for Leqembi (also known as lecanemab), a medicine to treat mild cognitive impairment in the early stages of Alzheimer’s disease, under strict conditions.
It is for use in people who have only one or no copy of the ApoE4 gene and who have amyloid beta plaques in the brain. It is the first such medicine to be authorised in the EU.
The ASI is heartened by the potential for this treatment – the first disease modifying therapy for Alzheimer’s disease – to become available in Ireland, which will undeniably offer hope for many people and families affected by Alzheimer’s. This follows several years of research, during which Leqembi showed positive results in clinical trials. The European Commission’s decision represents a landmark step forward and pivotal moment in the treatment of Alzheimer’s disease, following decades of failed treatment development attempts.
This is a critical juncture for the future of dementia care, and it is essential that Ireland now prepares for the swift integration of Leqembi (and next generation of treatments in the clinical pipeline) into our healthcare system, ensuring that those who can avail of this treatment are able to access it as soon as possible.
Read The ASI’s statement and reaction to this news here.
What is the future of drug treatments for Alzheimer’s Disease?
We await the next steps as to how / when Leqembi may be made available in Ireland. There are also several other disease modifying therapies in the pipeline, including Donanemab (described below).
While we are optimistic about the positive impact Leqembi will have, it is important to note that it is not a cure for Alzheimer’s Disease and will only be suitable for a small number of people in the early stages. Leqembi is a first-generation Disease Modifying Therapy with modest effects and some potential side effects. Continued investment and innovation in dementia services, support, and timely diagnosis is essential.
The ASI remains committed to working alongside healthcare professionals and policymakers to provide the best support for people living with dementia and their families across Ireland.
Other Media
17th April 2025 – Dr. Laura O’Philbin wrote an Op-Ed article for The Irish Examiner. Read here, or you can download and read here.
*Last updated: 30/09/2025
On 25th September 2025, The European Commission granted EU authorisation for Donanemab across all EU Member States. This decision comes after the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) gave a positive recommendation Eli-Lilly’s request to approve Donanemab in July, following an earlier negative decision. This medicine is intended for the treatment of early Alzheimer’s Disease (mild cognitive impairment and mild dementia).
The CHMP found that the benefits of Donanemab outweigh the risks for a specific population, those who do not carry the APoE4 gene. Because of this, they recommended that the medicine be approved for use. This decision follows other regulators such as the FDA in the United States (approved in July 2024) and in other countries such as Qatar, Japan, the United Kingdom, Kuwait, Singapore, Taiwan, Brazil and Australia.
During this re-examination, the CHMP also mandated additional measures to reduce risk, including noting that Donanemab should be administered under supervision with a clinical team, monitoring and management of ARIA (amyloid-related imaging abnormalities).
Read the European Medicines Agency’s overview here.
Read the European Medicines Agency summary of opinion here.
What are the next steps for Kisunla ?
Eli-Lilly has received approval for the use of Kisunla for the treatment of Alzheimer’s Disease by the European Medicine Agency. We now await next steps which will take place at national levels where Health Technology Assessment bodies will evaluate the treatment’s value and make decisions on reimbursement and access.
September 2025: ASI Reaction to the approval of Kisunla by the EMA
“We have now entered a promising new phase where two evidence-based therapies for early-stage Alzheimer’s are approved across all EU member states. Encouragingly, progress in the safety profile of these treatments is already advancing, bringing optimism that continued improvements in both safety and efficacy are on the horizon.
Kisunla is not a cure and is suitable only for a small subset of people with early-stage Alzheimer’s Disease. However, its approval represents a meaningful step forward in our understanding and treatment of Alzheimer’s disease at its earliest stages.
The ASI remains committed to advocating and supporting people affected by all types of dementia, and across all stages. We look forward to working closely with healthcare providers and policymakers in Ireland to ensure fair and timely access to this treatment for those who may benefit from these therapies.”
Read our statement in full on this update by clicking HERE.
You can also read Eli-Lilly’s statement HERE.
Other Media
17th July 2023 – The Alzheimer Society of Ireland Welcomes Positive Results from Donanemab Trial: Press Release HERE.
The ASI’s Research & Policy Manager, Dr. Laura O’Philbin, appeared on RTÉ’s Prime Time to discuss donanemab. You can watch this back HERE.
Dr. Laura O’Philbin also joined Virgin Media One’s The Tonight Show to further discuss donanemab. You can watch it back HERE (starting at approx 24.00).
Dr. Laura O’Philbin also appeared on RTE Radio One’s Morning Ireland to speak about Donanemab in the Irish context. You can listen back HERE.
