FDA Advisory Committee Votes Unanimously to Confirm the Clinical Benefit of LEQEMBI® (lecanemab-irmb) for the Treatment of Alzheimer's Disease
Peripheral and Central Nervous System Drugs Advisory Committee voted based on data from large global confirmatory Phase 3 Clarity AD clinical trial in patients living with early Alzheimer’s disease
The PDUFA action date for traditional approval of LEQEMBI has been set for July 6, 2023, with designation of priority review
LEQEMBI received accelerated approval from the FDA for the treatment of early Alzheimer’s disease on January 6, 2023
TOKYO and CAMBRIDGE, Mass., June 09, 2023 (GLOBE NEWSWIRE) -- Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusetts, CEO: Christopher A. Viehbacher, “Biogen”) announced today that the U.S. Food and Drug Administration’s (FDA) Peripheral and Central Nervous System Drugs Advisory Committee (PCNS) voted unanimously that the data from Eisai’s Phase 3 Clarity AD clinical trial confirms the clinical benefit of LEQEMBI® (lecanemab-irmb) 100 mg/mL injection for intravenous use for the treatment of Alzheimer’s disease (AD). Additionally, the committee members confirmed the overall benefit-risk profile of LEQEMBI, the clinical meaningfulness of the data and discussed its use in specific subgroups, including Apolipoprotein E (ApoE) e4 homozygote patients, patients requiring concomitant treatment with anticoagulant agents, and patients with cerebral amyloid angiopathy.
The unanimous decision by the panel of independent experts was based on the supplementary Biologics License Application (sBLA) which includes data from Eisai’s large global confirmatory Phase 3 Clarity AD trial. The Clarity AD trial met its prespecified primary endpoint, demonstrating a highly statistically significant slowing of cognitive and functional decline (27%, p=0.00005) compared to placebo over 18 months. Highly statistically significant treatment effects were also observed for all multiplicity-controlled secondary endpoints that examined cognition and functional changes using other validated scales. The most common adverse events (>10%) in the LEQEMBI group were infusion reactions (LEQEMBI: 26.4%; placebo: 7.4%), ARIA-H (combined cerebral microhemorrhages, cerebral macrohemorrhages, and superficial siderosis: LEQEMBI: 17.3%; placebo: 9.0%), ARIA-E (edema/effusion: LEQEMBI: 12.6%; placebo: 1.7%), headache (LEQEMBI: 11.1%; placebo: 8.1%), and fall (LEQEMBl: 10.4%; placebo: 9.6%). Infusion reactions were largely mild-to-moderate (grade 1-2: 96%) and occurred on the first dose (75%). The 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 [nejm.org].
LEQEMBI, a humanized immunoglobulin gamma 1 (IgG1) monoclonal antibody directed against aggregated soluble (protofibril*) and insoluble forms of amyloid beta (Aß), received accelerated approval on January 6, 2023, and was launched in the U.S. on January 18, 2023. The accelerated approval was based on Phase 2 data that demonstrated that LEQEMBI reduced the accumulation of Aß plaque in the brain, a defining feature of AD. Its continued approval may be contingent upon verification of LEQEMBI’s clinical benefit in the confirmatory Clarity AD trial (Study 301). The advisory committee agreed unanimously that Study 301 verified the clinical benefit. The Prescription Drug User Fee Act (PDUFA) action date for the traditional approval is July 6, 2023.
Eisai serves as the lead of lecanemab development and regulatory submissions globally with both companies co-commercializing and co-promoting the product and Eisai having final decision-making authority.
LEQEMBI has been approved under the FDA accelerated approval pathway. Click here for the Prescribing Information [leqembi.com].
INDICATION, DOSAGE AND ADMINISTRATION, AND IMPORTANT SAFETY INFORMATION IN THE U.S.
IMPORTANT SAFETY INFORMATION
Amyloid Related Imaging Abnormalities
ARIA Monitoring and Dose Management Guidelines
Incidence of ARIA
Apolipoprotein E e4 (ApoE e4) Carrier Status and Risk of ARIA
Concomitant Antithrombotic Medication and Other Risk Factors for Intracerebral Hemorrhage
Please see full Prescribing Information [leqembi.com] in the United States.
*Protofibrils are large Aß aggregated soluble species of 75-5000 Kd.1,2,3
Notes to Editors
1. About LEQEMBITM (lecanemab-irmb)
Eisai has also submitted applications for approval of lecanemab in Japan, EU, China, Canada, Great Britain and South Korea. In Japan and China, the applications have been designated for priority review, and in Great Britain, lecanemab has been designated for the Innovative Licensing and Access Pathway (ILAP), which aims to reduce the time to market for innovative medicines.
Eisai has completed lecanemab subcutaneous bioavailability study, and subcutaneous dosing is currently being evaluated in the Clarity AD (Study 301) OLE. A maintenance dosing regimen has been evaluated as part of Study 201 as well as the Clarity AD (Study 301) OLE. Separate supplemental Biologics License Applications for subcutaneous dosing and a maintenance dosing regimen will be submitted to the FDA at the end of Eisai's fiscal year.
Since July 2020 the Phase 3 clinical study (AHEAD 3-45) for individuals with preclinical AD, meaning they are clinically normal and have intermediate or elevated levels of amyloid in their brains, is ongoing. AHEAD 3-45 is conducted as a public-private partnership between the Alzheimer’s Clinical Trial Consortium that provides the infrastructure for academic clinical trials in AD and related dementias in the U.S, funded by the National Institute on Aging, part of the National Institutes of Health, Eisai and Biogen.
Since January 2022, the Tau NexGen clinical study for Dominantly Inherited AD (DIAD), that is conducted by Dominantly Inherited Alzheimer Network Trials Unit (DIAN-TU), led by Washington University School of Medicine in St. Louis, is ongoing.
2. About the Collaboration between Eisai and Biogen for AD
3. About the Collaboration between Eisai and BioArctic for AD
4. About Eisai Co., Ltd.
In addition, we demonstrate our commitment to the elimination of neglected tropical diseases (NTDs), which is a target (3.3) of the United Nations Sustainable Development Goals (SDGs), by working on various activities together with global partners.
For more information about Eisai, please visit www.eisai.com [eisai.com] (for global headquarters: Eisai Co., Ltd.), and connect with us on Twitter @Eisai_SDGs.
5. About Biogen
Biogen Safe Harbor
These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements, including without limitation unexpected concerns that may arise from additional data, analysis or results obtained during clinical studies, including the Clarity AD clinical trial and AHEAD 3-45 study; the occurrence of adverse safety events; risks of unexpected costs or delays; the risk of other unexpected hurdles; regulatory submissions may take longer or be more difficult to complete than expected; regulatory authorities may require additional information or further studies, or may fail or refuse to approve or may delay approval of Biogen's drug candidates, including lecanemab; actual timing and content of submissions to and decisions made by the regulatory authorities regarding lecanemab; uncertainty of success in the development and potential commercialization of lecanemab; failure to protect and enforce Biogen's data, intellectual property and other proprietary rights and uncertainties relating to intellectual property claims and challenges; product liability claims; third party collaboration risks; and the direct and indirect impacts of the ongoing COVID-19 pandemic on Biogen's business, results of operations and financial condition. The foregoing sets forth many, but not all, of the factors that could cause actual results to differ from Biogen's expectations in any forward-looking statement. Investors should consider this cautionary statement as well as the risk factors identified in Biogen's most recent annual or quarterly report and in other reports Biogen has filed with the U.S. Securities and Exchange Commission. These statements are based on Biogen's current beliefs and expectations and speak only as of the date of this news release. Biogen does not undertake any obligation to publicly update any forward-looking statements, whether as a result of new information, future developments or otherwise.
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