NEW YORK – In a reversal, the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) on Thursday recommended marketing authorization for Eisai and Biogen's Leqembi (lecanemab) for Alzheimer's disease.
CHMP, in July, recommended against the anti-amyloid drug's approval, doubtful of Leqembi's risk-benefit profile based on the results from the CLARITY AD Phase III trial. In that trial, Leqembi-treated patients had a 27 percent slower rate of cognitive decline than those given placebo and scored an average 0.45 points better on the 18-point Clinical Dementia Rating-Sum of Boxes (CDR-SB) scale than patients on placebo. However, the agency noted that the difference in scores between the groups was small and did "not counterbalance the risk of serious side events," like amyloid-related imaging abnormalities (ARIA).
Eisai requested that CHMP review its earlier decision, leading to the new opinion.
The US Food and Drug Administration granted Leqembi full approval last year, despite questions from many healthcare providers about whether the clinical trial data reflect meaningful improvements in patients' daily functioning. Leqembi is also approved in Japan, China, South Korea, Hong Kong, and Israel.
The European Commission will now consider CHMP's opinion in deciding whether to grant Leqembi marketing authorization in the EU.