EMA Reverses Decision, Recommends Approval of Lecanemab (Leqembi) for Early Alzheimer’s Disease in Specific Patient Group

EMA Reversal:
The European Medicines Agency (EMA) has reversed its previous negative decision and now recommends the approval of lecanemab (Leqembi) for the treatment of early Alzheimer’s disease in adult patients who are apolipoprotein E ε4 (ApoE ε4) non-carriers or heterozygotes with confirmed amyloid pathology1 4 5.

Patient Population:
The approval is restricted to patients with mild cognitive impairment or mild dementia due to Alzheimer’s disease, specifically those with one or no copies of the ApoE4 gene variant, who are at lower risk of amyloid-related imaging abnormalities (ARIA)1 4 5.

Clinical Trial Results:
The Clarity AD clinical trial showed that lecanemab reduced clinical decline on the global cognitive and functional scale, CDR-SB, by 31% at 18 months compared to placebo in the recommended patient population1.

Safety Measures:
To mitigate risks, lecanemab will be accessible through a controlled program, with patients undergoing MRI scans to monitor for ARIA before starting treatment and at specific intervals during treatment4 5.

Final Decision:
The European Commission is expected to make a final decision on the marketing authorization application (MAA) of lecanemab based on the CHMP recommendation within 67 days1 4.

Global Impact:
This decision marks a significant milestone in the global fight against Alzheimer’s disease, offering a new treatment option that can slow the progression of cognitive and functional deficits associated with the disease2 3 4.