On 30 November, Eisai presented the results of their confirmatory Phase 3 clinical trial (CLARITY AD) at the 15th Clinical Trials on Alzheimer’s Disease (CTAD) conference in San Francisco, USA.
The results, in line with their previous announcement in September, report that after 18 months, people living with dementia receiving lecanemab saw a reduction in the rate of cognitive decline by around 27%. While the treatment is yet to undergo regulatory approval by the Food and Drug Administration (FDA), European Medicines Agency (EMA) and other regulators, many are optimistic by the data presented by Eisai and welcome what this will may mean for the millions of people affected by Alzheimer’s disease and for future investment in research.
The data presented, which was simultaneously published in the New England Journal of Medicine, stimulates some important and timely next step questions relating to filing for approval with regulatory bodies, in the US, Europe and around the world. After 20 years of research frustrations and negative trials, a treatment offering meaningful change demands the timely attention of regulators.
At the time of the release of the results, ADI CEO Paola Barbarino said:
The Alzheimer’s and dementia community has been used to, for years, the ups and downs of possible therapeutic breakthroughs, which then turn up not to deliver. Behind all these failures are many people wo have devoted their lives, careers and hopes to helping the millions living with dementia and Alzheimer’s all over the world.
“A few hours ago, lecanemab’s latest results have been published and they look good. Put simply, it is a positive study that shows 24-37% efficacy on multiple cognitive and functional measures. I say this with caution as this will need more time and more investigation.”
The results of the trial also raise important questions relating to the preparedness of health systems across the world and their potential ability to accommodate lecanemab and any future emerging treatments, if regulatory approval is granted. Having advocated for health system preparedness for over two decades, ADI reiterates that it is important that governments take note and implement the necessary policies to ensure that those living with dementia can access treatments, if and when they are made available and that they are affordable.
For people affected by Alzheimer’s disease, time is of the essence. ADI eagerly awaits more details on the next steps for a treatment that could enable people to live independently for longer and spend more time with family and loved ones.
We will continue to provide further information on this process as it becomes available.