USA – Japanese drugmaker Eisai Co. has filed for a faster approval process with the FDA for the approval of its experimental drug for Alzheimer’s disease (AD), lecanemab.
The request follows the approval of Aduhelm, also known as aducanumab, in June, which works similarly to lecanemab in reducing the buildup of amyloid beta plaques in patients’ brains.
The Biogen/Eisai drug Aduhelm was the first Alzheimer’s treatment to receive FDA approval in nearly 20 years, but the Food and Drug Administration’s (FDA) controversial use of the accelerated approval process – which authorizes drugs for severe conditions without strong proof of a benefit to patients – has drawn widespread criticism.
Lecanemab is currently in Phase III of the AHEAD 3-45 trials, with 1,795 subjects enrolled. AHEAD 3-45 is a project funded by Eisai and the National Institute on Aging in collaboration with the Alzheimer’s Clinical Trial Consortium.
According to preliminary data, it is possible to identify participants across the Alzheimer’s disease continuum who are at risk for amyloid accumulation and cognitive decline for trials targeting underlying Alzheimer’s disease pathology.
Currently, Eisai, is using data from a midstage trial to show that its drug candidate removes brain plaques better than Aduhelm while causing less brain swelling.
Eisai plans to submit its application to the FDA on a rolling basis, with the goal of finishing it within a few months.
The company intends to submit data from its midstage trial of 856 volunteers, which revealed that after 18 months of treatment, 80 percent of patients had no amyloid left in their brains.
Alzheimer’s disease is now one of the most pressing issues confronting global public health, resulting in a burden of care that has a significant impact on families, communities, and healthcare systems alike.
Currently more than 55 million people live with neurodegenerative disease worldwide, and there are nearly 10 million new cases every year, with over 60 percent living in low- and middle-income countries
Lecanemab portends good tidings for those burdened by the AD. It works by selectively binding to and neutralizing soluble, toxic protofibrils that contribute to neurodegeneration.
Accordingly, it may have the potential to influence disease pathology and slow the progression of Alzheimer’s disease.
The FDA has agreed that the results of Clarity Alzheimer’s disease, once completed, can serve as a confirmatory study to validate the clinical benefit of lecanemab.
Additionally, the FDA has agreed to avail blinded safety data from Clarity Alzheimer’s disease will be to support the Biologics License Application (BLA).
Eisai acquired the worldwide rights to research, develop, manufacture, and market lecanemab. The Japanese biopharma company announced a collaboration with Biogen in March 2021 to develop and commercialize the drug upon approval, which is expected to culminate in end of September 2022.