Prime Highlights:
- The European Union approved Kisunla, an Alzheimer’s drug by Eli Lilly, for treating mild cognitive impairment and early-stage Alzheimer’s dementia under strict conditions.
- The decision reflects efforts to balance innovation in Alzheimer’s treatment with patient safety amid ongoing debate over the drug’s effectiveness.
Key Facts:
- Kisunla contains the antibody donanemab and can only be administered to patients in early-stage Alzheimer’s who do not carry a genetic mutation that increases side effect risks.
- Clinical trials showed the drug reduces disease progression, but serious risks like haemorrhages and cerebral oedemas remain, which can sometimes be fatal.
Background
The European Union on Thursday approved the Alzheimer’s drug Kisunla, produced by US pharmaceutical firm Eli Lilly, under strict conditions, amid ongoing debate over its effectiveness. The EU authorisation allows the drug to treat mild cognitive impairment and early-stage Alzheimer’s dementia.
Kisunla contains the antibody donanemab and is considered a breakthrough treatment, alongside Biogen and Esai’s Leqembi, which was conditionally approved by the EU in late 2024.
Clinical trials have demonstrated unprecedented effects to reduce disease progression but medical experts are still divided. Both Kisunla and Leqembi carry serious risks, including haemorrhages and cerebral oedemas, which can sometimes be fatal.
The EU allows Kisunla to be administered only to patients in the early stages of Alzheimer’s and only if they do not carry a genetic mutation that increases side effect risks. Member states are free to decide on reimbursement policies.
In early September, France ruled that Leqembi would not receive an accelerated reimbursement procedure, though it may consider it in the future. The United Kingdom has approved both drugs but will not cover costs due to high prices relative to limited benefits. In the United States, both drugs are authorised, but reimbursement is left to private health insurers.
The EU’s decision reflects ongoing efforts to balance innovation in Alzheimer’s treatment with patient safety and cost considerations.
