Biogen/Eisai’s Alzheimer’s drug shows continued cognitive improvement in long-term study
Leqembi was granted traditional US approval last year to treat patients in the early stages of the disease. Biogen and Eisai’s Alzheimer’s disease (AD) drug has shown continued benefits in patients with early stages of the neurodegenerative disease, according to three-year data presented at this year’s Alzheimer’s Association International Conference.
Leqembi (lecanemab-irmb) was granted traditional US approval in July 2023 for use as an intravenous (IV) infusion in patients with mild cognitive impairment or early-stage AD. The US Food and Drug Administration’s decision was supported by data from the phase 3 confirmatory Clarity AD clinical trial, in which the drug reduced clinical decline by 27% compared with placebo at 18 months.
Eisai, which serves as the lead for the drug’s development and regulatory submissions globally, has now presented positive results from an open-label extension of the study. The companies noted that a change from 0.5 to one on the CDR is “the difference between slight impairment and loss of independence”, such as the ability to be left alone, remember recent events and participate in daily activities.
The study also found that AD worsens after patients stop treatment with the drug, even after amyloid plaque clearance.
Additionally, no new safety findings were observed with continued Leqembi treatment over three years, with the majority of amyloid-related imaging abnormalities occurring in the first six months of treatment.
The results come just days after the European Medicines Agency’s human medicines committee decided not to recommend Leqembi for early AD, noting that its benefits were not large enough to outweigh its risks.
Eisai said it will seek re-examination of the Committee for Medicinal Products for Human Use’s opinion and will work with the relevant authorities “to ensure the treatment is available for eligible people living with early AD in the EU as soon as possible”.
Beyond its IV formulation, Eisai and Biogen have a subcutaneous version of the drug, which has been granted Fast Track designation by the FDA and is under review for weekly maintenance dosing in patients who have completed the bi-weekly IV initiation phase.
August 1, 2024
