FDA approves LEQEMBI Alzheimer’s treatment

Eisai Co., Ltd. and Biogen Inc. has announced that the US Food and Drug Administration (FDA) has approved an additional Biological License Application (sBLA) that supports approval of traditional LEQEMBI (lecanemab-irmb) 100 mg/mL injection for intravenous use.

The decision makes LEQEMBI the first and only approved treatment shown to reduce disease progression rates and slow cognitive and functional decline in adults with Alzheimer’s disease (AD).

LEQEMBI demonstrates clinically significant slowing of cognitive and functional decline in a cohort of patients generalizable to US Medicare beneficiaries, which includes a mix of racial and ethnic groups, patients with common comorbid conditions, concomitant medications, and patients with mild cognitive impairment (MCI) due to AD or mild AD.

Treatment with LEQEMBI should be started in patients with MCI or mild dementia, (collectively referred to as early AD) populations where treatment was started in clinical trials.

THIS GROUPtrial data

LEQEMBI’s traditional approval is based on phase 3 data from Clarity AD Eisai’s large and global clinical trials, in which LEQEMBI met its primary endpoint and all major secondary endpoints with statistically significant results and confirmed 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 in CDR-SB by 27% at 18 months compared to placebo. Additionally, the secondary end point of the AD Cooperative Study-Activities of Daily Living Scale for Mild Cognitive Impairment (ADCS MCI-ADL), as measured by caregivers of patients with AD, recorded a statistically significant benefit of 37%. It measures the patient’s ability to function independently, including being able to dress, feed independently and participate in community activities.

Following traditional FDA approval for LEQEMBI, CMS confirmed that a wider range of LEQEMBI is now available and released further details about the registry, including an easy-to-use data submission process. A CMS-enabled registry is now available for healthcare professionals to submit necessary patient data to CMS. Eisai said he was pleased that Medicare would pay for therapy for suitable patients. This will facilitate reimbursement and access to LEQEMBI in a variety of healthcare settings in the US

“Today, the FDA approved LEQEMBI under traditional approval pathways, making LEQEMBI the first and only anti-amyloid Alzheimer’s disease treatment approved shown to reduce disease progression rates and slow cognitive impairment in the early and mild dementia stages of the disease. As a company focused on research and development based on our hhc (human health care) concept, we are proud that the results of AD Eisai’s research over the past 40 years have been recognized and communicated to people living with this disease in the United States, said Haruo Naito, chief executive officers at Eisai.

Educate doctors

“Alzheimer’s disease is a progressive and fatal disease that profoundly impacts not only those living with it, but also their loved ones, treatment partners and society. We are continuously working to create broad and simple LEQEMBI access for patients and to support diagnosis and treatment in the early stages of the disease. Eisai will work diligently to educate clinicians about the safe and appropriate use of LEQEMBI to maximize benefits for people living with early AD and their families.”

“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 advancement for a disease previously thought to be incurable. We want to express our sincere appreciation to those who have worked tirelessly to find treatments for this incessant disease, without them this progress would not be possible,” said Christopher A. Viehbacher, President and CEO of Biogen.

“Our focus now is going forward, working with Eisai with the aim of making LEQEMBI accessible to eligible patients as soon as possible.”

LEQEMBI is a humanized immunoglobulin gamma 1 (IgG1) monoclonal antibody directed against soluble aggregates (protofibrils) and the insoluble form of amyloid beta (Aβ). Critically, LEQEMBI targets and clears the most neurotoxic form of Aβ that continues to accumulate and removes existing plaque to treat this chronic progressive disease.

Comment

The Alzheimer’s Association applauded the announcement.

“This treatment, while not a cure, gives people in the early stages of Alzheimer’s disease more time to maintain their independence and do the things they enjoy,” said Joanne Pike, President and CEO of the Alzheimer’s Association.

“While we continue our efforts to find new targets and test new treatments, people living with this fatal disease deserve the opportunity to discuss and make choices with their doctors if an FDA-approved treatment is right for them.”

This is an important day for people living with early-stage Alzheimer’s disease and their families,” said Hugh Courtney, 60, of Concord, Mass., who was diagnosed with Alzheimer’s disease in 2020.

“I’m currently in a Leqembi clinical trial, so I’m very excited about the FDA approval today. This gives other people living with early-stage Alzheimer’s the opportunity to take medications that can slow the progression of their disease.”

The Alzheimer’s Drug Discovery Foundation (ADDF) also welcomed the news.

“This is encouraging news, and more importantly, Leqembi’s approval will serve as a catalyst to drive further development and investment in the Alzheimer’s pipeline,” said Howard Fillit, ADDF co-founder and chief science officer.

“We finally have some clarity around the modest effects of amyloid on cognitive decline. Now it is more important than ever to double down and broaden our focus on developing the next generation of drugs based on aging biology that can lead to combination therapy and precision medicine approaches.”