Eisai and Biogen Begin Rolling BLA for Subcutaneous Alzheimer's Therapy Leqembi

Eisai and Biogen have announced the commencement of a rolling Biologics License Application (BLA) for a subcutaneous version of their Alzheimer’s disease treatment, Leqembi (lecanemab). The application seeks approval for a weekly maintenance dose administered via an autoinjector. If this subcutaneous formulation is approved, it would be an option for patients who have completed the biweekly initiation phase with the intravenous version of Leqembi. This new method of administration would allow patients to continue their treatment at home, though the option for administration at medical facilities would remain available.

The rolling BLA is backed by data from the open-label extension phase of the Phase III Clarity AD study and modeling results derived from observed data. The new formulation is designed to maintain effective drug levels in the body, making it potentially more convenient for patients and their caregivers. According to Eisai and Biogen, subcutaneous maintenance dosing could reduce the frequency of hospital visits, which could be beneficial for patients with limited mobility or those living far from medical facilities.

One of the key advantages of subcutaneous Leqembi is its potential to sustain the clearance of toxic protofibrils. These protofibrils are a highly toxic form of amyloid-beta proteins, which are known to contribute to nerve damage and cognitive decline in Alzheimer’s patients. By targeting and reducing these protofibrils, the treatment could slow the progression of the disease.

In April 2024, Biogen and Eisai announced a delay in their plans to file the BLA for the subcutaneous Leqembi injection by their initial March 2024 target. The companies initially intended to pursue the rolling BLA under Leqembi’s existing Fast Track and Breakthrough Designation. However, the FDA clarified that a separate Fast Track designation would be required for the subcutaneous formulation. As a result, the companies filed a supplemental BLA for a monthly maintenance intravenous dosing regimen instead.

Leqembi is a humanized IgG1 monoclonal antibody designed to target both soluble and insoluble amyloid-beta plaques in the brain. By tagging these plaques for clearance, the drug aims to prevent cognitive disruption. The FDA granted Leqembi accelerated approval in January 2023 based on biomarker data showing reduced amyloid-beta levels in the brain. In July 2023, the FDA awarded full approval to Leqembi, making it the first anti-amyloid antibody to receive traditional approval for Alzheimer’s disease.

Despite receiving full approval and broader coverage by the Centers for Medicare & Medicaid Services (CMS), the uptake of Leqembi has been slower than anticipated. In February 2024, Eisai disclosed that they would likely fall short of their target to treat 10,000 patients by March 2024. Nonetheless, Biogen reported an uptick in Leqembi sales in its first-quarter earnings for 2024, generating $19 million in Q1. Eisai projects that Leqembi’s revenue will total approximately $360 million for the fiscal year 2024, spanning from April 2024 to March 2025.

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