Biogen and Eisai have submitted a marketing authorisation application (MAA) to the UK’s medicines and healthcare products regulatory agency (MHRA) for lecanemab to treat early Alzheimer’s disease (AD).
Lecanemab is an investigational anti-amyloid beta (Aβ) protofibril antibody that will be used to treat mild cognitive impairment caused due to AD and mild AD dementia in people with the confirmed presence of amyloid pathology in the brain.
It is a humanised immunoglobulin gamma 1 (IgG1) monoclonal antibody directed against aggregated soluble (protofibril) and insoluble Aβ forms.
Biogen stated that the therapy has been designed to bind selectively and eliminate the soluble, toxic Aβ aggregates (protofibrils) believed to contribute to neurotoxicity in AD.
The regulator has also designated the therapy for the innovative licensing and access pathway (ILAP).
The submission of MAA is based on the findings from the Phase III Clarity AD trial and Phase IIb clinical study (Study 201).
Treatment with lecanemab demonstrated a clinical reduction in cognitive decline in early AD. The Clarity AD trial showed significant results and met its primary and all key secondary endpoints.
Eisai and Biogen recently announced that Health Canada has accepted a new drug submission for lecanemab to treat early AD.
The therapy also received approval from the US Food and Drug Administration (FDA) under the accelerated approval pathway to treat AD in January 2023.
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