The European Medicines Agency (EMA) has recommended the approval of the Alzheimer's drug Leqembi (Lecanemab) for a specific group of patients in the EU.
This marks a significant shift from their previous stance in July, where the drug was not approved due to concerns over severe side effects.
Leqembi is designed to slow the progression of Alzheimer's by targeting the underlying disease processes rather than just alleviating symptoms.
The approval is limited to patients with one or no copies of the ApoE4 gene, as they have a lower risk of side effects like brain swelling and bleeding.
Developed by Eisai and Biogen, Leqembi is already approved in the US and UK.
The EU Commission is expected to follow the EMA's recommendation, paving the way for the first Alzheimer's therapy in the EU that addresses the disease's root causes.