Biogen: UK marketing authorisation for Alzheimer's disease

(CercleFinance.com) - Biogen and its Japanese partner Eisai announce that their Leqembi (trade name for lecanemab) has received marketing authorisation (MA) from the Medicines and Healthcare products Regulatory Agency (MHRA) in Great Britain.


Lecanemab is thus indicated for the treatment of mild cognitive impairment and mild dementia due to Alzheimer's disease, in adult patients who are heterozygous or non-carriers of apolipoprotein E ε4 (ApoE ε4).

With this decision, lecanemab becomes the first treatment for early-onset Alzheimer's disease targeting an underlying cause of the disease to be approved in a European country, and the UK the first European country to approve the drug.

The MA is based primarily on phase 3 data from Eisai's Clarity AD clinical trial, in which the drug met its primary endpoint and all key secondary endpoints with statistically significant results.


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