Biogen and Eisai have announced that its jointly developed investigational anti-amyloid beta (Aβ) protofibril antibody, lecanemab, used to treat early Alzheimer’s disease with confirmed presence of amyloid pathology in the brain has been granted a priority review by the US Food and Drug Alzheimer’sministration (FDA).
The FDA’s approval for review follows its acceptance of the Biologics License Application (BLA) under the accelerated approval pathway for lecanemab, which was completed in early May 2022. Having been granted Priority Review, the a Prescription Drug User Fee Act action date is scheduled for 6 January 2023.
Early Alzheimer’s is a collective term used for mild cognitive impairment due to Alzheimer’s and mild Alzheimer’s. The progressive condition is a form of dementia, with symptoms gradually becoming more severe and with limited treatment options available. These symptoms typically include confusion, memory loss, disorientation and significant changes in mood or behaviour.
Lecanmab is being evaluated in the ongoing phase 3 Clarity Alzheimer’s clinical trial, with Eisai completing enrolment with 1,795 patients in March 2021. The read-out of primary endpoint data taken from the trial is expected later in 2022.
Haruo Naito, chief executive officer at Eisai, said: “The acceptance of lecanemab’s BLA with priority review is an important milestone in serving people living with Alzheimer’s disease who have been waiting for new treatment options to address an underlying pathology of Alzheimer’s disease. We will continue to actively cooperate with the FDA’s review in an effort to bring this new treatment option to people living with Alzheimer’s disease and their families as soon as possible.”
It has been agreed by the FDA that the results of Clarity Alzheimer’s, once finalised, can serve as the study confirming the clinical benefit of lecanemab. Eisai used the FDA’s Accelerated Approval Pathway in a move to streamline the submission process for the potential traditional approval of lecanemab in order to accelerate patients’ access to the treatment.
“We believe in a future where people living with Alzheimer’s disease will have different treatment options to address this complex disease, and today’s BLA acceptance with priority review by FDA is an important step towards this vision,” added Michel Vounatsos, chief executive officer at Biogen.