Eli Lilly secures MHRA authorisation for Alzheimer’s treatment

The Medicines and Healthcare products Regulatory Agency (MHRA) has authorised the only amyloid plaque-targeting therapy that has shown evidence in support of terminating therapy following amyloid plaque removal, according to Eli Lilly and Company. Donanemab is indicated to treat adult patients in Great Britain with mild cognitive impairment and mild dementia due to Alzheimer’s.

Specifically, it has been granted a marketing authorisation for eligible patients who are apolipoprotein E ε4 (ApoE ε4) heterozygotes or non-carriers.

One of the benefits of the biologic treatment is that it can support the body to remove excess amyloid plaques and slow cognitive and functional decline, Eli Lilly stated.

The company’s injectable monoclonal antibody (mAb) is administered intravenously. In July, Chilamula Srija, Pharma Analyst at GlobalData, remarked that donanemab’s monthly dosing regimen reduces hospital visits “by half, presenting a potential advantage in patient convenience”.

This approval by the MHRA in Great Britain “is another significant step to ensure patients with Alzheimer’s disease can receive treatment with this new class of amyloid targeting therapies, which could give them more time in the early symptomatic stage of the disease to do what matters most to them,” explained Ilya Yuffa, Executive Vice President And President of Lilly International, Eli Lilly and Company. “Donanemab demonstrated meaningful results for people with early symptomatic Alzheimer’s disease… in [the Phase III] TRAILBLAZER-ALZ 2 study.”

Results from the TRAILBLAZER-ALZ 2 study were published in the Journal of the American Medical Association (JAMA) in July 2023.

Donanemab was approved by the US Food and Drug Administration (FDA) as Kisunla™ (donanemab-azbt) in July 2024. This was followed by regulatory approval in Japan in September 2024.