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Lecanemab (Leqembi) showed clinical benefit in early Alzheimer's disease and its risks do not appear to preclude traditional approval, FDA reviewers said in a briefing document ahead of an
advisory committee meeting.
The document signals FDA support for the monoclonal antibody even before the agency's Peripheral and Central Nervous System Drugs Advisory Committee meets Friday to discuss the drug and its
risk/benefit profile.
Lecanemab met its prespecified primary endpoint in a confirmatory study, demonstrating a statistically significant treatment effect compared with placebo, the agency said. The drug's safety
profile was "consistent with the findings observed in the original review of lecanemab and consistent with findings associated with the class of monoclonal antibodies directed against
aggregated forms of beta amyloid," the FDA reviewers added.
In January, lecanemab was approved under the accelerated approval pathway to treat Alzheimer's disease -- the second anti-amyloid agent approved for Alzheimer's this way, the first being
aducanumab (Aduhelm). As part of the accelerated approval, drugmakers Eisai and Biogen were required to conduct a postmarketing trial verifying lecanemab's clinical benefit.
That confirmatory study -- the phase III CLARITY AD trial -- showed that treatment with lecanemab led to modestly less decline on cognitive and functional measures in early Alzheimer's
disease, but was associated with adverse events.
The primary efficacy endpoint in CLARITY AD was the change from baseline to 18 months on the Clinical Dementia Rating-Sum of Boxes (CDR-SB), a scale that ranges from 0-18 with higher scores
indicating worse impairment.
From a baseline score of about 3.2 on the CDR-SB, mean worsening at 18 months was 1.21 with lecanemab and 1.66 with placebo, a difference of -0.45 (95% CI -0.67 to -0.23, P