LEQEMBI Granted FDA Approval for Slowing Alzheimer’s Disease Progression

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The U.S. Food and Drug Administration (FDA) authorized the sBLA for LEQEMBI® (lecanemab-irmb) 100 mg/mL injection for intravenous use for Eisai, a BioArctic AB partner. LEQEMBI is the first Alzheimer’s disease (AD) drug that has been authorized to reduce the disease’s progression and improve cognitive and functional deterioration. Furthermore, given that the drug has a Food and Drug Administration-approved label, Medicare will pay for LEQEMBI at full price, provided that real-world data are obtained through a publicly accessible patient registry. 

According to PR Newswire, LEQEMBI’s standard approval was based on the results of Phase 3 of Eisai’s worldwide Clarity AD clinical trial. The trial demonstrated that LEQEMBI had therapeutic benefit because it met its primary goal as well as all of the major secondary goals. The primary result was computed by aggregating individuals’ scores on the Clinical Dementia Rating (CDR-SB) scale, which evaluates both global cognitive and functional skills.

After 18 months, clinical deterioration on the CDR-SB was 27% slower in the LEQEMBI group compared to the placebo group in persons with early Alzheimer’s disease. There was also a 37% improvement on the AD Cooperative Study-Activities of Daily Living Scale for Mild Cognitive Impairment (ADCS MCI-ADL), a secondary goal evaluated by caregivers. This measure assesses patients’ independence in doing everyday chores such as dressing, eating, and engaging socially.  

Gunilla Osswald, CEO of BioArctic, is ecstatic with Medicare’s decision to cover a significant portion of LEQEMBI prescriptions and patient care. She referred to it as a “groundbreaking step” in the battle against Alzheimer’s disease, stressing that it will give doctors with a new technique to treat the illness from its early stages, with “meaningful clinical benefits” for patients and their families. Osswald asserted that the project’s twenty years of study and development were critical to its success.

She congratulated Eisai for its efforts to bring this vital discovery into the hands of the people BioArctic hopes to help, and she expressed hope for the future. The FDA’s Peripheral and Central Nervous System Drugs (PCNS) advisory group unanimously recommended clearance of LEQEMBI on June 9, 2023, based on findings from Eisai’s Clarity AD clinical study. LEQEMBI offers favorable clinical results and an appropriate risk-benefit profile, according to the committee.  

Following the FDA’s normal clearance of the LEQEMBI, an increase of coverage was announced, and further information on the patient registry, including a simple data reporting method, was made available. Because of the simplified registry, providers may now readily submit the essential patient data to CMS. As a result of this new policy and the shortened clearance process, LEQEMBI will be more widely covered and accessible in US healthcare systems. 

Professor Lars Lannfelt, Co-Founder of BioArctic and Inventor of LEQEMBI, has expressed his joy that the therapy is now available to patients more than 25 years after his original findings. His major objective was to find a way to eliminate the harmful soluble amyloid beta (A) oligomers and protofibrils that develop in Alzheimer’s sufferers’ brains.

While appreciating the advancements, Lannfelt stressed the need for BioArctic and others to continue their research in order to give patients with additional alternatives. Eisai will be in charge of Lecanemab’s global development and regulatory filings, while the company and Biogen will work on marketing and sales. BioArctic is collaborating with Eisai to plan a potential joint commercial launch in the Nordic countries, while BioArctic retains the right to sell lecanemab. 

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