Leqembi(lecanemab)

Leqembi (lecanemab) is indicated for the treatment of Alzheimer’s disease. Treatment should be initiated in patients with mild cognitive impairment or mild dementia stage of disease, the population in which treatment was initiated in clinical trials. The drug received regulatory approval on July 6, 2023.

In efficacy trials, Leqembi demonstrated a change from baseline in brain amyloid plaque (SUVR) of -0.310 and -73.5 Centiloids. The probability of the 10 mg/kg biweekly regimen being superior to placebo by 25% (ADCOMS) was 64%. Significant amyloid beta plaque reduction (PET SUVR) versus placebo was observed starting at Week 13 (p<0.0001), and maintained at Week 53 (p<0.0001) and Week 79 (p<0.0001). The proportion of treatment effect on CDR-SB explained by amyloid PET SUVR (10 mg/kg biweekly) was 95%.

Notable safety findings include a symptomatic ARIA incidence of 3%, with serious symptomatic ARIA occurring in 0.7% of patients. Overall ARIA incidence (including asymptomatic radiographic events) was 21%. ARIA-E incidence was 13% and ARIA-H incidence was 17%. Resolution of clinical symptoms associated with ARIA was observed in 79% of cases.