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June 24, 2021updated 02 Dec 2021 12:44pm

FDA grants breakthrough status to Eisai and Biogen’s Alzheimer’s drug 

The breakthrough designation is based on positive data from the Phase IIb Study 201 trial in Alzheimer’s patients. 

The US Food and Drug Administration (FDA) has granted breakthrough therapy designation to Eisai and Biogen’s lecanemab (BAN2401) for Alzheimer’s disease (AD) treatment.

Developed through a partnership between Eisai and BioArctic, lecanemab is an investigational, humanised anti-amyloid beta (Aβ) protofibril monoclonal antibody (mAb) for AD.

The mAb specifically attaches to neutralise and remove soluble, toxic Aβ 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.

According 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, Eisai and Biogen signed a deal 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’s 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 Alzheimer’s Clinical Trial Consortium, which is funded by the US National Institutes of Health’s National Institute on Aging, and Eisai.

Last week, the US Food and Drug Administration granted accelerated approval to Biogen and Eisai’s Aduhelm (aducanumab-avwa) for the treatment of Alzheimer’s disease.

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