Approvals

Japanese Eisai and US-based biotechnology company Biogen have announced that the US Food and Drug Administration (FDA) has given their Alzheimer’s disease (AD) drug Leqembi (lecanemab-irmb) full approval through the approval of a supplemental Biologics License Application (sBLA). This will allow wider medical insurance coverage in the US.

Leqembi is a humanised immunoglobulin gamma 1 (IgG1) monoclonal antibody directed against aggregated soluble and insoluble forms of amyloid beta (Aβ). It works by targeting and clearing the most neurotoxic form of Aβ that accumulates on the brain, as well as removing existing plaque. While the drug cannot reverse memory loss and other related side effects, it has shown to slow clinical decline.

In order to receive the approval, the companies conducted the phase 3 CLARITY AD multicentre, randomised clinical trial, which enrolled 1,795 patients with AD to verify the drug’s effectiveness. The primary endpoint was the global cognitive and functional scale, Clinical Dementia Rating Sum of Boxes (CDR-SB), with the secondary endpoint being AD Cooperative Study-Activities of Daily Living Scale for Mild Cognitive Impairment (ADCS MCI-ADL), measured by the carers of the patients. Overall the trial found a ‘statistically significant and clinically meaningful reduction’ in cognitive decline in patients taking Leqembi.

Haruo Naito, CEO at Eisai, commented: “Today, the FDA approved Leqembi under the traditional approval pathway, making [it] the first and only approved anti-amyloid AD 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 human healthcare (HHC) concept, we are proud that the results of Eisai’s AD research over the past 40 years have been recognised and delivered to people living with this disease in the US. AD 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. Eisai will diligently work to educate physicians on the safe and appropriate use of Leqembi to maximise its benefit to people living with early AD and their families.”

Christopher A Viehbacher, president and CEO of Biogen, stated: “Today marks a breakthrough in the treatment of AD, 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.”