06:31 AM EDT, 08/22/2024 (MT Newswires) -- Biogen (BIIB) and Japan's Eisai Co. ( ESALF ) said early Thursday that their humanized amyloid-beta monoclonal antibody, lecanemab, received marketing authorization from the UK's regulatory authority.
The company said lecanemab is indicated for the treatment of mild cognitive impairment and mild dementia due to Alzheimer's disease in certain types of adult patients. It targets an underlying cause of Alzheimer's disease.
The approval from the Medicines and Healthcare products Regulatory Agency was primarily based on phase 3 data from an Eisai ( ESALF ) clinical trial. Lecanemab met its primary endpoint and all of its key secondary endpoints, producing statistically significant results.
Eisai ( ESALF ) is working with the National Institute for Health and Care Excellence, the Scottish Medicines Consortium, and the National Health Service to make this medicine available to eligible patients "as soon as possible."
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