Leqembi is a humanised immunoglobulin gamma 1 (IgG1) monoclonal antibody therapy, initially approved to treat AD in adults, under the US FDA’s Accelerated Approval pathway, which is now converted to traditional approval
Leqembi granted FDA traditional approval. (Credit: Myriams-Fotos from Pixabay)
Eisai and Biogen announced that the US Food and Drug Administration (FDA) has granted traditional approval for Leqembi (lecanemab-irmb) to treat Alzheimer’s disease (AD) in adults.
The US health regulator approved the companies’ supplemental Biologics License Application (sBLA) for Leqembi, making it the first and only approved treatment in this indication.
Leqembi is a humanised immunoglobulin gamma 1 (IgG1) monoclonal antibody therapy that works by reducing amyloid plaques in the brain, a defining feature of the disease.
In January this year, the drug was approved in the US, to treat adult patients with Alzheimer’s Disease, under the FDA’s Accelerated Approval pathway.
The US FDA now converted Leqembi to traditional approval, following a determination that a confirmatory trial verified clinical benefit.
According to the US FDA, Leqembi is the first amyloid beta-directed antibody to be converted from an accelerated approval to a traditional approval for the treatment of AD.
Biogen president and CEO Christopher A Viehbacher said: “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.
“We would like to express our sincere appreciation to those who have worked tirelessly to find a treatment for this unrelenting disease, without whom this progress would not be possible.
“Our focus is now on the path forward, working alongside Eisai with the goal of making Leqembi accessible to eligible patients as soon as possible.”
The traditional approval of Leqembi is based on data from Eisai’s Phase 3 Clarity AD clinical trial, in which the drug met its primary endpoint and all key secondary endpoints.
In the study, Leqembi showed statistically significant results with confirmed clinical benefits.
The AD treatment reduced clinical decline on the Clinical Dementia Rating Sum of Boxes (CDR-SB) scale by 27% compared to placebo, which was the primary endpoint.
The secondary endpoint, AD Cooperative Study-Activities of Daily Living Scale for Mild Cognitive Impairment (ADCS MCI-ADL), noted a statistically significant benefit of 37%.
In addition, the Centres for Medicare and Medicaid Services (CMS) has announced a wider coverage of Leqembi, with an easy-to-use data submission process.
Furthermore, Eisai has launched Understanding ARIA, an initiative to further advance the management and monitoring of amyloid-related imaging abnormalities (ARIA).
Eisai CEO Haruo Naito said: “We are proud that the results of Eisai’s AD research over the past 40 years have been recognized and delivered to people living with this disease in the United States.
“Alzheimer’s disease is a progressive, fatal disease that greatly impacts not only the people living with it, but also their loved ones, care partners and society.
“We continue to work to create broad and simple access to Leqembi for patients and to support diagnosis and treatment at the early stage of the disease.