Source – Eisai
On July 6, 2023, Eisai and Biogen received full approval from the FDA for their Alzheimer’s disease medication, lecanemab, also known as Leqembi. This traditional approval comes six months after the drug was granted accelerated approval. With this milestone, Leqembi is no longer bound by strict coverage determination from the Centers for Medicare & Medicaid Services (CMS).
“Today, the FDA approved LEQEMBI under the traditional approval pathway, making LEQEMBI the first and only approved anti-amyloid Alzheimer’s disease treatment shown to reduce the rate of disease progression and to slow cognitive impairment in the early and mild dementia stages of the disease. As a research and development-focused company based on our hhc (human health care) concept, 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. 2 Eisai will diligently work to educate physicians on the safe and appropriate use of LEQEMBI to maximize its benefit to people living with early AD and their families.”
– Haruo Naito, Chief Executive Officer at Eisai
Leqembi received accelerated FDA approval in January based on its ability to reduce amyloid beta plaque, a marker associated with Alzheimer’s disease and believed to be linked to improved outcomes.
For full approval, the companies submitted data demonstrating the drug’s effectiveness on an endpoint called the Clinical Dementia Rating-Sum of Boxes after 18 months of treatment. This endpoint assesses the severity of dementia to diagnose and evaluate a patient’s condition.
“That box warning is an important way to signal to prescribers that it’s important that they understand ARIA and important that they be able to educate and communicate with patients and caregivers about it so that they can have very informed discussions about risk and benefit,” Hersch said.
The FDA committee of outside experts unanimously voted in favor of Leqembi’s clinical benefit, describing the trial data as robust, meaningful, consistent, and significant.
Eisai’s VP of clinical research for new modalities and neurology, Steven Hersch, expressed satisfaction with Leqembi’s label. He explained that it presents data from the drug’s Phase III Clarity AD trial and that the indication is similar to what was granted during accelerated approval.
“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.”
– Christopher A. Viehbacher, President and Chief Executive Officer of Biogen
The label also indicates minimal limitations on prescribing Leqembi to Alzheimer’s patients, including factors such as patient genotype or potential contraindications with concomitant medications.
Safety concerns, particularly related to amyloid-related imaging abnormalities (ARIA), have led to the inclusion of a boxed warning. Eisai expects this warning to apply to all future anti-amyloid class Alzheimer’s drugs, as ARIA rates and timing may vary between products. However, Hersch noted that the rates of ARIA for Leqembi are relatively low.
Given these considerations, it is crucial for neurologists and prescribers to enhance their understanding of ARIA compared to previous practices. To facilitate this, Eisai has developed educational materials and programs, including the Understanding ARIA website.
This recent regulatory milestone goes beyond a simple approval and holds significant significance for the launch of Leqembi. The decision is particularly important because the Centers for Medicare and Medicaid Services (CMS) has pledged to enhance accessibility to Alzheimer’s drugs approved through the FDA’s traditional pathway. To achieve this, the CMS has introduced a registry approach, allowing coverage of Alzheimer’s drugs even after accelerated approval, in order to continue gathering valuable data as the drugs are made available. Prior to obtaining full approval, Leqembi, along with other Alzheimer’s treatments granted accelerated approval, could only be covered within clinical trial settings to facilitate the ongoing collection of data.
