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The European Union on Thursday authorized the extremely contentious Alzheimer’s medicine Kisunla underneath strict circumstances, with the drug’s effectiveness hotly debated by the medical group.
“The European Commission has granted EU marketing authorization for Kisunla, a medicine to treat mild cognitive impairment, including mild dementia in the early stages of Alzheimer’s disease,” the fee introduced in a press release.
Produced by US multinational Eli Lilly, the lively substance of Kisunla is the antibody donanemab.
It’s thought of a breakthrough type of remedy for Alzheimer’s illness together with Biogen’s and Esai’s Leqembi.
However the precise advantages of each medicine have provoked a heated medical debate.
On the one hand, they’ve proven an unprecedented impact throughout scientific trials after many years of unsuccessful analysis aimed toward slowing affected person deterioration.
Alternatively, this impact stays minimal, and a few consultants argue that the distinction for sufferers isn’t substantial sufficient.
They’ll additionally trigger extreme and generally even deadly unwanted effects, primarily hemorrhages and cerebral edemas.
Primarily based on suggestions from its European Medicines Company (EMA), the EU granted advertising and marketing authorization for Leqembi in late 2024, underneath strict circumstances and after initially refusing to take action.
It did the identical for Kisunla, which was additionally authorized after an preliminary rejection: now, it might solely be administered to sufferers within the early phases of Alzheimer’s, and provided that they don’t have a genetic mutation that predisposes them to unwanted effects.
The authorization offers EU member states free rein concerning reimbursement.
In early September, France determined that Leqembi didn’t warrant an accelerated process for reimbursement approval, though it has not fully dominated out the likelihood in the long run.
Exterior the EU, the UK has authorized each remedies however won’t reimburse them, deeming the fee too excessive for such restricted advantages.
The USA, each remedies have been approved, however reimbursement is on the discretion of personal well being insurers.
© 2025 AFP
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EU approves contentious Alzheimer’s medicine (2025, September 26)
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