FDA grants biologics license application for monthly IV Leqembi

The FDA has accepted Eisai and Biogen’s biologics license application for a monthly infusion of IV Leqembi to treat individuals with mild cognitive impairment or mild dementia consistent with early stage Alzheimer’s disease.

“The FDA’s acceptance of the Leqembi subcutaneous maintenance dosing [biologics license application] is important for patients in the early stages of Alzheimer’s disease because early and ongoing treatment has shown to slow the progression, helping patients maintain who they are for longer,” Tatsuyuki Yasuno, chairman and CEO of Eisai Inc., told Healio in an email.

According to a joint release from manufacturers Eisai and Biogen, the approval was based on data from the phase 3 CLARITY-AD clinical trial and its subsequent open-label extension.

In the main study, enrollees were randomly assigned on a 1:1 basis to receive either 10 mg/kg IV Leqembi (lecanemab, Eisai/Biogen) infusion or placebo every 2 weeks for 18 months.

In the open-label extension, at 36 months, results showed the mean change in Clinical Dementia Rating Scale-Sum of Boxes (CDR-SB) of those given early initiation of lecanemab was approximately 3.1 and for those with later initiation 3.5. Treatment also reduced symptom worsening at 18 months as measured by the CDR-SB.

Eisai and Biogen submitted the application in early 2024 based on these data. Should the FDA grant full approval to lecanemab, it will become the only AD treatment that patients can administer subcutaneously at home using an autoinjector.

The FDA has set a Prescription Drug User Fee Act action date for August 31.