The FDA accepted Biogen and Eisai’s BLA for a subcutaneous administration of the anti-amyloid antibody Monday as the partners await the regulator’s decision on a new intravenous regimen following an underwhelming launch riddled with coverage and accessibility barriers.
As Biogen and Eisai await an FDA decision later this month on a monthly maintenance regimen of Leqembi, the regulator has accepted a biologics license application for a subcutaneous maintenance formulation of the Alzheimer’s therapy.
The convenience factor of subcutaneous administration could be exactly what the product—fraught with controversy over efficacy and an underwhelming launch—needs to gain a foothold in the market. Since its accelerated FDA approval in early 2023, Leqembi’s sales continue to be underwhelming, according to analysts. In November, Eisai cut 2024 fiscal guidance for the antibody from $370 million to $280 million.
Though nearly seven million Americans are estimated to be living with Alzheimer’s disease, barriers of Medicare coverage, infusion center accessibility and time to diagnosis are cited by analysts as the main issues holding back sales. While coverage may continue to be an issue regardless of formulation, infusion center accessibility is one that could be remedied with a subcutaneous, at-home injection.
The BLA is based on data from Clarity AD, an open-label extension study, and would include a 360 mg weekly maintenance regimen of the monoclonal antibody for patients who have completed the biweekly intravenous initiation phase. A PDUFA date is set for August 31, 2025.
Biogen and Eisai are already anticipating a verdict on a monthly intravenous maintenance regimen of Leqembi. The FDA is expected to decide on this application by January 25. Both maintenance regimens are designed to help maintain therapeutic levels of Leqembi in the body to suppress the formation of toxic protofibrils, which can result in nerve damage and brain injury even after amyloid-beta has been cleared.
Eisai touted a strong demand for Leqembi in its fiscal year 2024 presentation, claiming around 6,000 patients are waiting for the therapy—a therapy that may be more easily accessible if at-home administration is approved.
