The US Food and Drug Administration recently granted approval under its Accelerated Approval Pathway to the monoclonal antibody lecanemab-irmb, marketed as Leqembi, that dissolves beta-amyloid protein plaques in the brain and developed jointly by Eisai Pharmaceutical and Biogen for the treatment of mild Alzheimer's disease (AD).

Describing the development as an important advancement in the ongoing fight to effectively treat the devastating disease, the drug regulator stated that lecanemab is the second of a new category of medications approved for AD, which targets its fundamental pathophysiology, in a recent media statement.

“Alzheimer’s disease immeasurably incapacitates the lives of those who suffer from it and has devastating effects on their loved ones,” the director of the Office of Neuroscience in the FDA’s Center for Drug Evaluation and Research, Dr Billy Dunn, said.

“This treatment option is the latest therapy to target and affect the underlying disease process of Alzheimer’s, instead of only treating the symptoms of the disease,” he added.

"The FDA's approval of Leqembi under the Accelerated Approval pathway is an important milestone in Eisai's four decades of research in Alzheimer's disease and reflects our continued commitment to alleviating the burden of Alzheimer's disease for patients and their families," said Eisai's Chief Executive Officer, Haruo Naito.

“The challenges of Alzheimer’s disease reach beyond medical implications for patients and considerations for their families, but also impact society as a whole through reduced productivity, elevated social costs and anxiety,” he pointed out.

Following this Accelerated Approval, the company stated that it will focus on providing important information on the proper use of the drug to healthcare professionals.

“Eisai will also engage with various payers to provide access to Leqembi, offer a patient support program, and will do its utmost to complete submission for traditional approval as soon as possible to serve more people living with early Alzheimer’s disease,” Naito added.

“The approval of  Leqembi provides new hope to patients with Alzheimer’s disease. Patients at an early stage of the disease and their caregivers can now consider a new treatment option with their doctors. Our focus now is on the path forward, working alongside Eisai with the goal of making Leqembi available to patients who may benefit from this treatment as soon as possible,” President and Chief Executive Officer of Biogen, Christopher A. Viehbacher said.

Pointing out that the two companies have collaborated for over a decade in developing treatments for Alzheimer’s Disease, the Biogen official added, “This approval is also a recognition of the many scientists and doctors who have, over many years, patiently and persistently worked to find a treatment for this highly complex disease.”

The USFDA stated that the drug has shown to have an effect on a surrogate endpoint that is reasonably likely to predict a clinical benefit to patients in the results of a clinical trial to confirm the drug's clinical benefit, and the agency expects to receive the data soon.