The US Food and Drug Administration (FDA) has granted breakthrough therapy designation to and 鈥檚 lecanemab (BAN2401) for Alzheimer鈥檚 disease (AD) treatment.
Developed through a partnership between Eisai and BioArctic, lecanemab is an investigational, humanised anti-amyloid beta (A尾) protofibril monoclonal antibody (mAb) for AD.
The mAb specifically attaches to neutralise and remove soluble, toxic A尾 aggregates or protofibril that are believed to cause the neurodegenerative process in AD.
Eisai noted that lecanemab could potentially target disease pathology and delay disease progression.
The FDA based its designation on positive results from the Phase IIb Study 201 trial in 856 subjects with mild cognitive impairment (MCI) due to AD and mild AD with confirmed amyloid pathology.
According to pre-specified analysis from this proof-of-concept trial, lecanemab was found to offer a consistent decrease in clinical decline on various clinical and biomarker goals at its highest dose levels.
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By GlobalDataAccording to an agreement concluded in December 2007, Eisai received rights to study, develop, produce and commercialise lecanemab from BioArctic for AD treatment globally.
In March 2014,聽Eisai and Biogen signed a deal聽to co-develop and co-market lecanemab. The agreement was later revised in October 2017.
Currently, the antibody is being analysed in Phase III Clarity-AD clinical trial in symptomatic early AD patients. This trial concluded enrolment of 1,795 subjects in March.
The companies anticipate concluding the trial鈥檚 primary goal by the end of September next year.
In July last year, Eisai and Biogen launched the Phase III AHEAD 3-45 trial in people with preclinical AD.
AHEAD 3-45 is being carried out as a public-private partnership between the , which is funded by the US National Institutes of Health鈥檚 National Institute on Aging, and Eisai.
Last week, the US Food and Drug Administration granted accelerated approval to Biogen and Eisai鈥檚 Aduhelm聽(aducanumab-avwa) for the treatment of Alzheimer鈥檚 disease.
