EMA gives partial go-ahead for first Alzheimer’s treatment in EU
The European Medicines Agency (EMA) has recommended the EU approve its first treatment for Alzheimer’s among certain patients. The treatment slows the progress of the disease.
Treatment with the active substance lecanemab, which is marketed under the brand name Leqembi, is recommended in patients in whom the disease is not yet at an advanced stage. It was authorised in the US in 2023.
The recommendation only applies to patients with only one or no copy of a specific gene, ApoE4. People with two copies are at higher risk of side effects, such as swelling and bleeding in the brain.
The EMA rejected the first application for approval in July as it judged the risks of side effects to be too high. But it now considers that for a specific group of patients “the benefits of Leqembi in slowing down progression of symptoms of the disease are greater than its risks”. Patients receiving the treatment – an infusion every fortnight – have to undergo regular monitoring.
It is now up to the European Commission to rule on market authorisation for Leqembi, which is made by Japanese pharma company Eisai and the US-based Biogen.
Other Alzheimer’s drugs treat only the symptoms of the disease.
Illustration © PHOTO IMAGEBROKER
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