Eisai submits supplemental biologics license application to FDA for monthly IV Leqembi
Click Here to Manage Email Alerts
Eisai and Biogen have submitted a supplemental biologics license application to the FDA for monthly IV maintenance dosing of Leqembi to treat Alzheimer’s disease in patients with mild cognitive impairment or mild dementia.
According to a joint press release, patients who have completed the biweekly IV initiation phase of Leqembi (lecanemab-irmb) would receive a monthly IV dose at an effective drug concentration to maintain clearance of toxic protofibrils, which are responsible for neuronal injury even after amyloid-beta plaques are cleared from the brain. The companies based their application in part on data from the phase 3 Clarity AD study and its open-label extension.
“Leqembi provides the opportunity for therapeutic intervention that can change the course of this progressive and relentless disease, caused by a continuous underlying neurotoxic process,” Lynn D. Kramer, MD, FAAN, Eisai’s chief clinical officer of deep human biology learning, told Healio in an email. “If approved by the FDA, a once-monthly Leqembi IV maintenance dose will be an important and potentially more convenient option for treating Alzheimer’s disease.”
Eisai intended to submit a biologics license application (BLA) in March 2024 for weekly maintenance therapy via subcutaneous administration, but with the FDA’s recent requirement for additional 3-month immunogenicity data, the company instead planned to initiate a rolling BLA for subcutaneous maintenance at 360 mg weekly under existing fast track and breakthrough therapy designations.
However, according to the release, Eisai was informed by the FDA that a fast track designation specific for the subcutaneous formulation would be necessary to receive rolling review. In response, the company submitted a fast track request for the subcutaneous formulation and will initiate a rolling submission should the FDA grant its request.
The fast track designation will be determined within 60 days from the March 2024 submission, the company stated. Leqembi is approved in the United States, Japan and China.