On 28th September, Eisai announced it has initiated a rolling review to the U.S. Food and Drug Administration (FDA) of a Biologics License Application under the accelerated approval pathway for lecanemab, an immunotherapy designed to target protofibrillar forms of amyloid beta. It will represent the second therapy seeking approval as disease modifying treatment by the FDA since Biogen’s Aduhelm (aducanumab). A rolling review means that parts of the Biologics License Application can be submitted and reviewed by the FDA on an ongoing basis rather than waiting for a completed application. This follows a previous FDA decision in June 2021, to grant lecanemab Breakthrough Therapy designation.
The data for the submission is based primarily on the results a proof-of-concept Study 201 in 856 people living with early Alzheimer’s disease (mild cognitive impairment due to AD and mild AD) with confirmed presence of amyloid. The authors of the study claim that lecanemab cleared amyloid plaques (measured by PET scan), slowed cognitive decline at the highest doses and impacted cerebrospinal fluid biomarkers of Alzheimer’s disease pathophysiology. The Phase-3 trial for lecanemab completed enrolment in March 2021 and is currently ongoing.
Dementia is the collective name for progressive degenerative brain syndromes which affect memory, thinking, behaviour and emotion. Alzheimer’s disease is the most common type of dementia, contributing to 60-80% of cases.
Paola Barbarino, Chief Executive Officer of ADI remains cautiously optimistic about the news of a disease modifying treatment and hopes that it will be accessible to all those living with dementia who are eligible.
After so long without any treatment for Alzheimer’s disease, we are pleased to see that there is now a renewed sense of interest and research into this area by pharmaceutical companies. Those living with dementia have gone too long without a treatment and we await the result of the FDA’s assessment. In the meantime, we hope that measures are put in place to ensure that healthcare systems are ready for a new breakthrough and that it is affordable and accessible for everyone who may need it.
The need for a treatment for Alzheimer’s disease for those living with dementia and their carers was mirrored by Haruo Naito, Chief Executive Officer at Eisai, who said: “With population growth and aging worldwide, the number of people living with Alzheimer’s disease will rise dramatically. Alzheimer’s disease has an extremely high unmet medical need, not only for people living with Alzheimer’s disease and their families, but also for society”.
While Eisai has initiated a rolling review with the FDA, the primary endpoint for their Phase III trial will not expected readout until late 2022, at which point it will serve as the confirmatory study to verify the clinical benefit of lecanemab. ADI will continue to advocate to ensure that if approved, lecanemab will be accessible to all those who are eligible, and that the health systems are prepared with the required resources in place to enable it to be prescribed by clinicians.