USFDA grants traditional approval for Eisai Leqembi for Alzheimer's disease treatment
Stockholm:BioArctic AB's (publ)partner Eisai has announced that the U.S. Food and Drug Administration, FDA, has approved the supplemental Biologics License Application, sBLA, supporting the traditional approval of LEQEMBI (lecanemab-irmb) 100 mg/mL injection for intravenous use, making LEQEMBI the first and only approved treatment shown to reduce the rate of disease progression and to slow cognitive and functional decline in adults with Alzheimer's disease (AD). In conjunction with the approval the Centers for Medicare and Medicaid Services, CMS, announced that Medicare will provide broad coverage of LEQEMBI according to the FDA approved label provided that real-world evidence is collected in an easy-to-use patient registry.
LEQEMBI's traditional approval is based on Phase 3 data from Eisai's large, global Clarity AD clinical trial, in which LEQEMBI met its primary endpoint and all key secondary endpoints with statistically significant results and confirmed the clinical benefit of LEQEMBI. The primary endpoint was the global cognitive and functional scale, Clinical Dementia Rating Sum of Boxes (CDR-SB). LEQEMBI treatment reduced clinical decline on CDR-SB by 27% at 18 months compared to placebo in an early Alzheimer's disease population. Additionally, the secondary endpoint of AD Cooperative Study-Activities of Daily Living Scale for Mild Cognitive Impairment (ADCS MCI-ADL), as measured by people caring for patients with AD, noted a statistically significant benefit of 37%. This measures the ability of patients to function independently, including being able to dress, feed themselves and participate in community activities.
"The full, traditional approval of LEQEMBI in the US, combined with the broad Medicare reimbursement, is a paradigm-shifting step in the fight against Alzheimer's disease," said Gunilla Osswald, CEO of BioArctic. "Doctors in the US will now have a tool to combat this terrible chronic disease already at an early stage, with the potential to provide clinically meaningful benefit for patients and their families. More than two decades of research and development has led up to this moment, and I am impressed by the diligent efforts of our partner Eisai to ensure that this important innovation can now reach the patients BioArctic was founded to serve. I am full of gratitude and hope for the future."
On June 9, 2023, the FDA's Peripheral and Central Nervous System Drugs (PCNS) advisory committee voted unanimously that the data from Eisai's Clarity AD clinical trial confirmed the clinical benefit of LEQEMBI for the treatment of AD. Committee members also confirmed the overall risk-benefit of LEQEMBI.
Importantly, following FDA's traditional approval of LEQEMBI, CMS confirmed that broader coverage of LEQEMBI is now available and released more details on the registry, including the easy-to-use data submission process. The CMS-facilitated registry is now available for healthcare professionals to submit required patient data to CMS. This will facilitate reimbursement for and access to LEQEMBI across a broad range of healthcare settings in the United States.
"More than 25 years after my initial discoveries, it is fantastic to finally see LEQEMBI becoming available to the patients who have always been my focus," said Professor Lars Lannfelt, Co-founder of BioArctic and inventor of LEQEMBI. "From the start, my idea was to find a way to clear the soluble amyloid beta (Aβ) oligomers and protofibrils, the most neurotoxic forms of Aβ, that continuously accumulate in the brain of Alzheimer disease patients. LEQEMBI was generated to do just that. But even if this is a great step forward, it is important for BioArctic and others to continue research to provide more options for patients."
Eisai serves as the lead of lecanemab development and regulatory submissions globally with both Eisai and Biogen co-commercializing and co-promoting the product and Eisai having final decision-making authority. BioArctic has the right to commercialize lecanemab in the Nordic region and currently Eisai and BioArctic are preparing for a joint commercialization in the region.
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