Eli Lilly Kisunla bags marketing authorization in Great Britain to treat mild cognitive impairment, mild dementia due to Alzheimer's Disease
Indianapolis: Eli Lilly and Company has announced that the Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorization for donanemab, an injection for intravenous infusion every four weeks to treat mild cognitive impairment and mild dementia due to Alzheimer's disease in eligible adults in Great Britain. Eligible patients are limited to apolipoprotein E ε4 (ApoE ε4) heterozygotes or non-carriers, which is a requirement for the class of currently approved amyloid-targeting therapies in Great Britain. Donanemab is the only amyloid plaque-targeting therapy with evidence to support stopping therapy when amyloid plaques are removed. Great Britain is the third major market to approve donanemab, marketed as Kisunla.
"People around the world want and deserve access to treatment options for this disease. This approval 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," said 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 by significantly slowing cognitive and functional decline in our TRAILBLAZER-ALZ 2 study."
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