As Eli Lilly meets with the US Food and Drug Administration (FDA) today [10 June] to discuss the approval for its Alzheimer’s drug donanemab, the company’s main competitors in the space – Eisai and Biogen – have said an expanded regimen of its drug Leqembi (lecanemab-irmb), which makes treatment “less burdensome” and “easier”, will be reviewed by early next year.
Co-developed by Esai and Biogen, Leqembi won full FDA approval last July in the form of a 100mg/mL injection for intravenous (IV) use. The FDA has now accepted Eisai’s supplemental biologics application (sBLA) for monthly Leqembi IV maintenance dosing for the treatment of patients with Alzheimer’s disease.
The agency has set a Prescription Drug User Fee Act (PDUFA) action date of 25 January 2025, according to a 9 June press release.
Eisai and Biogen stated that patients who have completed the bi-weekly IV initiation phase would be eligible to receive the monthly maintenance dose at an effective concentration to ensure efficacy. The exact duration of the initiation phase is still being discussed with the FDA.
Eisai and Biogen based the sBLA on modelling data from Phase II Study 201 (NCT01767311) and Phase III Clarity AD study (Study 301), along with both their respective open-label extensions (OLEs).
Leqembi works by clearing protofibrils in the brain. Protofibrils are considered to be the most toxic form of amyloid beta and have a key role in cognitive decline. Eisai and Biogen said that data from the aforementioned studies demonstrate that Leqembi treatment beyond the 18-month phase prolongs patient benefit due to protofibrils being continuously removed. The once-monthly regimen, if approved, is “less burdensome and easier for patients and care partners to continue long-term”, according to the pharma partners.
More efficient treatment is also the name of the game for another one of Eisai and Biogen’s Leqembi applications. Eisai initiated the rolling submission of a BLA for a subcutaneous autoinjector version of the drug for weekly maintenance dosing last month. The under-the-skin formulation could reduce the need for hospital visits and nursing care, the two companies said in a previous press release.
While the antibody-based therapy has made waves in the neurodegenerative disease space, its uptake has been hampered due to treatment logistics. Patients first require extensive imaging scans before taking the medication and often must travel to specialist sites for the infusion version.
Despite a tricky launch, Leqembi is predicted to see US sales of $4.6bn by 2030, according to GlobalData’s Pharma Intelligence Centre.
GlobalData is the parent company of Pharmaceutical Technology.
The fight for space in the Alzheimer’s treatment arena is heating up as Eli Lilly’s donanemab prepares to be under the FDA spotlight today in front of an advisory committee to discuss the drug’s approval. Biogen meanwhile has funnelled all resources into Leqembi after discontinuing its other Alzheimer’s asset, Aduhelm (aducanumab-avwa).
