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FDA Gives Conventional Approval to LEQEMBI® (lecanemab-irmb) for Alzheimer’s Disease Treatment

FDA's traditional approval of LEQEMBI® (lecanemab-irmb) heralds a new era for Alzheimer's disease (AD) treatment. The drug has demonstrated significant potential in reducing the rate of disease progression and slowing cognitive and functional decline in adults with AD.


Introduction

LEQEMBI, developed by Eisai Co., Ltd. and Biogen Inc., is the first and only approved treatment shown to alleviate the symptoms and progression of Alzheimer's disease. The FDA's traditional approval is based on Phase 3 data from Eisai's large, global Clarity AD clinical trial.


Key Details about LEQEMBI

LEQEMBI is a humanized immunoglobulin gamma 1 (IgG1) monoclonal antibody that targets aggregated soluble and insoluble forms of amyloid-beta (Aβ). It has the ability to clear the most neurotoxic form of Aβ and remove existing plaques, making it a potent weapon against this progressive, chronic disease.

LEQEMBI's Clinical Trials

The Clarity AD clinical trial demonstrated that LEQEMBI treatment reduced clinical decline on the global cognitive and functional scale by 27% at 18 months, compared to a placebo. The secondary endpoint noted a statistically significant benefit of 37%, which measures the ability of patients to function independently.

FDA's Traditional Approval

LEQEMBI's traditional approval was granted based on the Clarity AD clinical trial's results. The FDA's Peripheral and Central Nervous System Drugs (PCNS) advisory committee voted unanimously that the trial data confirmed LEQEMBI's clinical benefit for AD treatment.

Broader Medicare Coverage

Following FDA's traditional approval of LEQEMBI, CMS confirmed that broader coverage of LEQEMBI is now available. This will facilitate reimbursement for and access to LEQEMBI across a broad range of healthcare settings in the United States.

Company Statements on LEQEMBI Approval

Both Eisai and Biogen have expressed their commitment to making LEQEMBI accessible to eligible patients as soon as possible.

"Today marks a breakthrough in the treatment of Alzheimer’s disease, and we are proud to be at the forefront of ushering in a new era of advances for a disease that was previously considered untreatable," said Christopher A. Viehbacher, President and Chief Executive Officer of Biogen.

Patient Assistance Program

Eisai has established a Patient Assistance Program to provide LEQEMBI at no cost, for eligible uninsured and underinsured patients, including Medicare beneficiaries, who meet financial need and other program criteria.

Future Path for LEQEMBI

LEQEMBI's journey doesn't end with its FDA approval. Eisai is currently evaluating subcutaneous dosing in the Clarity AD open-label extension (OLE). The company plans to submit separate supplemental Biologics License Applications for subcutaneous dosing and a maintenance dosing regimen to the FDA at the end of Eisai's fiscal year.

Collaboration between Eisai and Biogen

Since 2014, Eisai and Biogen have been collaborating on the joint development and commercialization of AD treatments. Eisai leads the global development and regulatory submissions of LEQEMBI, with both companies co-commercializing and co-promoting the product.

Collaboration between Eisai and BioArctic

Eisai and BioArctic have had a long-term collaboration regarding the development and commercialization of AD treatments since 2005. Eisai obtained the global rights to study, develop, manufacture and market LEQEMBI for the treatment of AD pursuant to an agreement with BioArctic in December 2007.

Conclusion

With the FDA's traditional approval, LEQEMBI has become a beacon of hope for countless families grappling with the devastating impact of Alzheimer's disease. Its proven efficacy in slowing down cognitive and functional decline presents a significant milestone, ushering in a new era of advancements in Alzheimer's treatment.

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