On behalf of the more than 55 million people living with dementia and their families, of which Alzheimer’s is the biggest disease, ADI warmly welcomes the positive initial data reported today by Eisai and Biogen on the CLARITY AD global Phase 3 clinical trial of lecanemab.
On 28 September, Eisai and Biogen published a press release outlining the results of their Phase 3 study CLARITY AD. In the press release, it was reported that their treatment lecanemab significantly reduced cognitive and functional decline, achieving its primary end point for the trial. A clinical trial measures many parameters, the primary endpoint being the main metric used to determine the success of a study. The press release also reports that all secondary endpoints were also met.
In response to the results, Eisai will now begin discussions with regulatory authorities in the United States, Japan and Europe, with the intention of filing for marketing approval before April 2023.
An estimated 55 million people are living with dementia across the world, a number set to increase to 139 million by 2050, with dementia constituting the 7th leading cause of death worldwide. Alzheimer’s disease is the most common form of dementia, contributing to around 60-70% of cases worldwide.
In response to the news, ADI CEO Paola Barbarino said:
“We are delighted with the news that a new treatment for Alzheimer’s disease may soon be seeking approval in the United States, Japan and Europe. This will be welcome news to the millions of people who, up until this point, have been hoping for a treatment. We urge regulatory authorities to consider this treatment exactly in the same way as they would with other disease areas, avoiding the stigma, ageism and discrimination we so often observe in this field.”
If a treatment is available and its efficacy is clinically proven, the treatment should be made available by relevant regulatory and paying bodies to people who could benefit from it regardless of their age, socioeconomic status and geographical location. Not doing so can be considered an infringement of the human rights of older people. The choice of whether to undergo treatment or not, if offered by a medical professional, should of course lie with the individual.
While there are still a number of hurdles to overcome before lecanemab could be available to those living with dementia (including those outside of the United States, Japan and Europe), Ali Atri, Chair of ADI’s Medical and Scientific Advisory Panel, is hopeful for what a new treatment will mean to those living with Alzheimer’s disease:
Though these emerging drugs remain far from a cure, this is welcome news for patients and families, and positive top line results add to the preponderance of evidence that second-generation amyloid lowering monoclonal antibody drugs, by removing plaques, can provide clinical benefits; and that with sufficient diligence and rigor potential treatment-related side-effects can be detected, monitored and managed.
“They also add to the real promise, that we may do even better to slow the clinical progression of Alzheimer’s for those impacted now, and potentially even more so for the possibility of prevention of Alzheimer’s disease when given earlier in the course of disease or when administered in combination with other emerging drugs and/or lifestyle-interventional approaches.”
We will continue to provide further information on this process as it becomes available.