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Leqembi Alzheimer: HAS Refuses Early Access in France

by Dr. Michael Lee – Health Editor

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.

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