The panel’s backing was based on the sBLA, which includes findings from Eisai’s global confirmatory Phase 3 Clarity AD trial, which met its prespecified primary endpoint, showing a highly statistically significant slowing of cognitive and functional decline compared to placebo over 18 months
LEQEMBI is a humanised immunoglobulin gamma 1 monoclonal antibody. (Credit: Natasha Connell on Unsplash)
The Peripheral and Central Nervous System Drugs Advisory Committee (PCNS) of the US Food and Drug Administration (FDA) has unanimously agreed that the late-stage Clarity AD clinical trial of Eisai and Biogen’s LEQEMBI (lecanemab-irmb) confirms the clinical benefit in the treatment of Alzheimer’s disease (AD).
LEQEMBI is a humanised immunoglobulin gamma 1 (IgG1) monoclonal antibody that targets aggregated soluble and insoluble forms of amyloid beta (Aβ).
All the members of the PCNS confirmed LEQEMBI 100mg/mL injection’s overall benefit-risk profile and the clinical significance of the data and voted in its favour to treat Alzheimer’s disease.
They also discussed its use in particular subgroups, including those with cerebral amyloid angiopathy, patients who need concomitant treatment with anticoagulant agents, and Apolipoprotein E (ApoE) ε4 homozygote patients.
Biogen said that the panel’s backing was based on the supplementary biologics license application (sBLA) which includes findings from Eisai’s global confirmatory Phase 3 Clarity AD trial.
The trial met its prespecified primary endpoint, showing a highly statistically significant slowing of cognitive and functional decline compared to placebo over 18 months.
In addition, the results showed highly statistically significant treatment effects for all multiplicity-controlled secondary endpoints that assessed functional and cognition variations using other validated scales.
In January this year, LEQEMBI secured accelerated approval based on the data from a Phase 2 trial. The mid-stage study showed that the Eisai and Biogen’s drug reduced the accumulation of Aβ plaque in the brain.
The new Alzheimer’s drug was introduced in the US in January 2023.
In March, the US health regulator granted priority review for the traditional approval of LEQEMBI with the Prescription Drug User Fee Act (PDUFA) action date of 6 July 2023.