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The US Food and Drug Administration (FDA) has released a new briefing document which appears to show support for Eisai and Biogen’s new Alzheimer’s drug.
The document evaluates newer data on lecanemab (Leqembi) from the Phase 3 Study 301 (CLARITY AD) to confirm the clinical benefit of lecanemab for the treatment of Alzheimer’s disease.
The study was a placebo-controlled, double-blind, parallel-group, randomised study involving 1,795 people with early Alzheimer’s disease. The primary endpoint of the study was a change from baseline in the Clinical Dementia Rating at 18 months of treatment.
The document states: “Study 301 met its prespecified primary endpoint, demonstrating a statistically significant treatment effect in the lecanemab treatment arm compared to placebo.”
“Uncertainty” over whether lecanemab caused deaths of trial participants
However, the agency highlighted various safety concerns associated with Leqembi, including possible amyloid related imaging abnormalities (ARIA), cerebral haemorrhage, and infusion-related reactions and hypersensitivity, including an anaphylactic reaction.
In lecanemab treated patients the incidence of ARIA-E was 13% and the risk of ARIA-H was 17%. Additionally, two deaths occurred in subjects who had cerebral haemorrhage after treatment with lecanemab, and one death occurred in a patient with a possible cerebrovascular accident and severe ARIA-E and ARIA-H.
However, the agency say there is “uncertainty” regarding the role of lecanemab in these cases, including the role of concomitant medications, possible contribution of ARIA, the possible presence of cerebral amyloid angiopathy and related vasculitis and its role in such events.
They add that current prescribing information for lecanemab includes a warning for the risk of ARIA and provides recommendations for monitoring and dose management guidelines.
For these reasons, the briefing document states: “The risks can be described in the prescribing information and do not appear to preclude traditional approval of lecanemab.”
FDA to meet with external advisers
The FDA are meeting with a committee of external advisers on Friday (9 June) to discuss whether the efficacy data from Study 301 confirm the clinical benefit of lecanemab in the treatment of Alzheimer’s disease, and whether the benefit-risk assessment supports the traditional approval of lecanemab.
If the advisers agree there is a clinical benefit to the drug and that it has a good safety profile, Leqembi could soon be approved in the US.