A new Alzheimer’s disease (AD) treatment has been shown to reduce clinical decline in mild cognitive impairment (MCI) due to AD and mild AD with confirmed presence of amyloid pathology in the brain.
Eisai and Biogen’s anti-amyloid beta (Aβ) protofibril antibody lecanemab met the primary endpoint and all key secondary endpoints in the global Phase III Clarity AD clinical trial.
Eisai has stated its intention to file for regulatory approval in the US, Europe and Japan by March 2023.
The challenge of Alzheimer’s
Lecanemab treatment met the primary endpoint and reduced clinical decline on the global cognitive and functional scale, CDR-SB, compared with placebo at 18 months by 27%.
CDR-SB is a numeric scale used to quantify the various severity of symptoms of dementia; memory, orientation, judgment and problem solving, community affairs, home and hobbies, and personal care.
“Alzheimer’s disease not only presents a great challenge for patients and their families, but it also negatively impacts society, including decreased productivity, increased social costs and disease-related anxiety. We believe that helping to alleviate these burdens will positively impact society as a whole,” said Haruo Naito, Chief Executive Officer at Eisai.
“Additionally, the lecanemab Clarity AD study results…will create new horizons in the diagnosis and treatment of Alzheimer’s disease as well as further activate innovation for new treatment options.”
Greater inclusion of ethnic populations
The recruitment strategy for the Clarity AD clinical trial ensured greater inclusion of ethnic and racial populations in the US. This, and inclusive eligibility criteria, meant that Clarity AD’s population was generally comparable to the country’s Medicare population.
Michel Vounatsos, Chief Executive Officer at Biogen, added: “Importantly, the study shows that removal of aggregated amyloid beta in the brain is associated with a slowing of disease in patients at the early stage of the disease.
“We want to thank the many patients who participated in this groundbreaking global study and want to acknowledge the clinical investigators who worked tirelessly to increase the enrollment of traditionally underrepresented populations.”