Originally approved under the accelerated approval pathway, a final decision on a traditional approval for lecanemab is expected to come in early July.
Less than a few months after the FDA approved Eisai’s antiamyloid therapy lecanemab (Leqembi), it was announced that the US Veterans Health Administration (VHA) is providing coverage of the therapy to veterans living with early stages of Alzheimer disease (AD).1
In its statement, Eisai noted that it "looks forward to sharing additional high-quality data as it becomes available and to continuing discussions with the VHA as the company prepares for the FDA's potential conversion of Leqembi’s accelerated approval to a traditional approval." Additionally, the company was “proud of and humbled by the opportunity to support U.S. veterans as we strive to fulfill our human health care (hhc) mission."
Lecanemab, a humanized immunoglobulin gamma 1 (IgG1) monoclonal antibody, was first approved under the accelerated approval pathway, which requires Eisai to continue phase 4 testing to confirm its clinical benefit. Under this pathway, the agent, and other approved antiamyloid therapies, are not fully covered by the Centers for Medicare & Medicaid Services (CMS). Most recently, the FDA accepted Eisai’s supplemental biologics license application (sBLA) for the traditional approval of the agent, with a PDUFA action date set for July 6, 2023.2
Lecanemab is currently indicated for patients with mild cognitive impairment or mild dementia stage of disease, the population in which treatment was initiated in clinical trials. The finalization of CMS’s April 2022 decision to restrict the coverage of antiamyloid therapies included evidence available to the agency from that time point, and did not included updated data on lecanemab highlighting effects these therapies may bring.
In February 2023, CMS provided an update to the Alzheimer’s Association’s request to reconsider the final national coverage determination, stating the agency was not reconsidering changing its stance at this time. After a careful review of the request and supporting documentation, CMS believed there is not enough evidence yet to meet the criteria for reconsideration.3
The sBLA is based on findings from the phase 3 confirmatory Clarity AD study (NCT03887455), an 18-month trial that further demonstrated lecanemab’s effect in early AD. Published in the New England Journal of Medicine, Clarity AD included 1795 patients with evidence of amyloid on PET or cerebrospinal fluid who were followed for an 18-month treatment period. At the conclusion of the analysis, lecanemab met its primary end point of change in Clinical Dementia Rating-Sum of Boxes (CDR-SB) score, with treated patients demonstrating a statistically significant 27% reduction. Overall, lecanemab-treated patients showed adjusted least-squares (LS) mean changes of 1.21 vs 1.66 for those on placebo (P <.001).4