New Alzheimer’s Treatment Faces Roadblock in France Despite European Approval
A promising new treatment for early-stage Alzheimer’s disease, Leqembi (Lecanemab), will not be promptly available too French patients after the High Authority for Health (HAS) denied it’s request for early access on September 9th. The decision, which restricts access to the monoclonal antibody therapy, has drawn criticism from patient advocacy groups and raised concerns among some specialists.
The HAS cited a lack of clinically relevant efficacy and a “worrying tolerance profile” as justification for its refusal. This contrasts with the European Union’s decision in April to grant Leqembi a European marketing authorization (AMM), albeit with restrictions limiting its use to patients at the lowest risk of adverse effects.
Alzheimer’s disease is a complex and varied condition, frequently enough beginning subtly and impacting cognitive functions like memory, as well as possibly causing personality changes and diminished motivation. the disease typically progresses to a loss of independence, placing a important burden on both patients and their caregivers. France Alzheimer estimates that over 1.4 million people in France are currently affected by the disease.
The HAS decision arrives amidst renewed global research efforts targeting Alzheimer’s, a condition for which effective treatments remain limited. While Leqembi’s availability in France is currently stalled, its approval within the EU signals a potential shift in the landscape of Alzheimer’s care and fuels ongoing investigations into disease-modifying therapies.