Lecanemab accepted for review by Canadian authorities to treat early Alzheimer's disease.- Eisai/Biogen
Eisai and Biogen announced that Canadian health authorities have accepted for review an application for their anti-amyloid beta antibody lecanemab for the treatment of early Alzheimer’s disease (AD) with confirmed amyloid pathology in the brain.
The submission is based on data from the PIII Clarity AD trial and the PIIb Study 201 program, which demonstrated the drug’s efficacy in slowing clinical decline in early AD (mild cognitive impairment due to AD and mild AD dementia).
According to Eisai, Health Canada’s new drug review typically takes around 300 days. In the US, the drug secured an accelerated approval in January 2023 under the brand name of Leqembi, and it is currently pending full traditional approval, with the FDA’s target action date set for 6 July 2023. It has also been filed for regulatory approval in other markets, with decisions expected in Japan by September, and in Europe and China by March 2024.
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