Eisai starts clock ticking on approval filing for subcutaneous sibling to Alzheimer's drug Leqembi

Eisai’s full-throttle development of a subcutaneous sibling to recently approved Alzheimer’s disease drug Leqembi could bear fruit in the coming quarters, with the Biogen-partnered drugmaker aiming to file for approval in the next year or so.

The ink on the FDA approval of Leqembi, the twice-monthly intravenous version of lecanemab, is barely dry, but Eisai is already gearing up to expand its portfolio with a formulation that could increase uptake of the treatment. Eisai aims to file for regulatory approvals of the subcutaneous formulation in its next financial year, which starts April 1. 

Eisai disclosed the target in its third-quarter results. On an investor conference call to discuss the results, Ivan Cheung, global Alzheimer's disease officer at Eisai, named the launch of the subcutaneous version of lecanemab alongside wider adoption of blood tests as a milestone that could support growth.

The planned filing will rest on an open-label extension to Clarity AD, the phase 3 study that supported the approval of Leqembi, that is testing the effects of giving subcutaneous doses of lecanemab using an autoinjector. Eisai initially evaluated the formulation in a subcutaneous bioavailability study.

If approved, the subcutaneous formulation will enable patients to receive treatment via an injection, freeing them from the need to travel to an infusion center every two weeks. Earlier this month, Biogen CEO Chris Viehbacher said the subcutaneous formulation could be particularly valuable if lecanemab use expands into earlier-stage patients. At the time, Viehbacher ducked a question about the timeline for the subcutaneous formulation. 

Eisai is testing the subcutaneous formulation in parallel to a revised intravenous dosing schedule. Under the revised schedule, patients would receive maintenance doses of Leqembi every four weeks or every 12 weeks. Eisai plans to seek approval for the revised, less-burdensome schedule in its next fiscal year.