Eisai Co., Ltd. announced today that the U.S. Veterans’ Health Administration (VHA) is providing coverage of LEQEMBI (lecanemab-irmb) to veterans living with early stages of Alzheimer’s disease (AD). VHA healthcare professionals meeting the criteria set forth by the VHA can prescribe LEQEMBI to veterans who fit the VHA’s criteria and the U.S. Food and Drug Administration’s (FDA) current label. The VHA’s careful consideration and timely action to make LEQEMBI available approximately two months after the FDA approved LEQEMBI under the accelerated approval pathway shows its continued commitment to veterans living with AD.
If approved under the traditional pathway, the FDA will update the label for LEQEMBI, which will include new data that has been evaluated by the FDA. Eisai 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. Eisai is proud of and humbled by the opportunity to support U.S. veterans as we strive to fulfill our human health care (hhc) mission.
LEQEMBI is a humanized immunoglobulin gamma 1 (IgG1) monoclonal antibody directed against aggregated soluble (protofibrils*) and insoluble forms of amyloid beta (Aβ), LEQEMBI was approved in the U.S. under the Accelerated approval Pathway for the treatment of AD on January 6, 2023, and was launched in the U.S on January 18, 2023. Treatment with LEQEMBI should only be initiated in patients with mild cognitive impairment or mild dementia stage of disease and confirmed presence of Aβ pathology.
The Accelerated approval was based on Phase 2 data that demonstrated that LEQEMBI reduced the accumulation of Aβ plaque in the brain, a defining feature of AD, and its continued approval may be contingent upon verification of LEQEMBI’s clinical benefit in a confirmatory trial. The FDA has determined that the results of Clarity AD will serve as the confirmatory study to verify the clinical benefit of LEQEMBI.
On the same day that LEQEMBI received its Accelerated approval, Eisai submitted the supplemental Biologics License Application (sBLA) to the FDA for approval under the Traditional pathway. The sBLA was accepted by the FDA on March 3, 2023 and granted Priority Review with a Prescription Drug User Fee Act (PDUFA) date of July 6, 2023. The sBLA is based on the findings from Eisai’s recently published large, global confirmatory Phase 3 clinical trial, Clarity AD. LEQEMBI met the primary endpoint and all key secondary endpoints with highly statistically significant results. In November 2022, results of the Clarity AD study were presented at the Clinical Trials on Alzheimer’s Disease (CTAD) conference and simultaneously published in the peer-reviewed medical journal, The New England Journal of Medicine.
Eisai serves as the lead of LEQEMBI development and regulatory submissions globally with both Eisai and Biogen co-commercializing and co-promoting the product and Eisai having final decision-making authority.
*Protofibrils are large Aβ aggregated soluble species of 75-500 Kd.1
To learn more, visit www.leqembi.com/, www.eisai.com/news/2023/news202319.html.
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Topic: Press release summary