FDA Approves New IV Maintenance Dose of Leqembi

Alzheimer's puzzle © Orawan - stock.adobe.com

The FDA has approved a new maintenance dose regimen of Eisai and Biogen’s Alzheimer’s drug Leqembi (lecanemab-irmb), according to a recent news release.

The new regimen is an intravenous dose of 10 mg/mL of Leqembi once every four weeks, instead of once every two weeks, which may be easier on patients and their caregivers, the release states. Both maintenance doses begin after an 18-month initiation phase of 10 mg/mL of Leqembi every two weeks.

Alzheimer’s disease is an incurable neurodegenerative disorder that affects more than 6.5 million Americans. Although the root cause is unknown, it is characterized by the buildup of toxic amyloid-beta plaque and protofibrils. Leqembi works by continuously clearing both plaque and protofibrils, therefore slowing cognitive decline.

This approval is based on the results of phase 2 study called Study 201, the Clarity AD study and their long-term extensions.

Data from Study 201 showed that during the off-treatment period, there was a reaccumulation of amyloid PET and plasma and CSF biomarkers, when compared to placebo.

In the Clarity AD study, Leqembi reduced cognitive decline by -0.95 on the Clinical Dementia Rating-Sum of Boxes global cognitive and functional scale, when compared to placebo, which was -0.45. A higher score indicates greater dementia severity.

This change can be the difference between slight impairment and loss of independence, the release states.

Leqembi carries a risk of amyloid-related imaging abnormalities (ARIA), which appear as brain edema or sulcal effusions on an MRI. In Study 2, 27% of patients treated when Leqembi had ARIA, compared with 15% of patients taking placebo.

Additional Leqembi approvals include a 100 mg/mL weekly subcutaneous autoinjector, which has a Prescription Drug User Fee Act (PDUFA) action date set for Aug. 31, 2025. The injection takes about 15 seconds and can be administered at home, potentially reducing the need for hospital and infusion site visits.

Leqembi was approved for intravenous use by the FDA in July 2023.

The list price for Leqembi in the United States is $26,500 a year with out-of-pocket cost varying by patient and insurance provider.