Biogen: English marketing application for lecanemab


(CercleFinance.com) – Eisai Co and Biogen Inc. announced yesterday that Eisai has submitted a marketing authorization (MA) application to the UK Medicines and Healthcare products Regulatory Agency (MHRA) for lecanemab.

The latter, an investigational anti-amyloid beta protofibrillar antibody, for the treatment of early-stage Alzheimer’s disease with confirmed amyloid pathology in the brain, has been designated by the MHRA to benefit from the Innovative Licensing and Access Pathway (ILAP ).

The marketing authorization is based on the results of the confirmatory phase III Clarity AD study and the phase IIb clinical study, which demonstrated that treatment with lecanemab reduced clinical decline in early-stage Alzheimer’s disease .

Eisai is responsible for lecanemab’s development and marketing authorization applications worldwide. Eisai and Biogen jointly market and promote the product, and Eisai has final decision-making authority.

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