FDA Accepts Eisai's Leqembi Monthly Dosing Application, Decision Due Jan. 25

Leqembi, a collaborative Alzheimer's disease medication developed by Eisai and Biogen, has garnered significant regulatory attention globally, receiving approvals in the U.S., Japan, China, and South Korea. Recently, Eisai has made noteworthy progress in its regulatory efforts for the drug, specifically focusing on enhancing its dosing convenience.

The U.S. Food and Drug Administration (FDA) has accepted Eisai's application for a monthly intravenous (IV) maintenance dosing alternative for Leqembi. The administration is expected to deliver its decision by January 25, 2025. Presently, Leqembi is administered bi-weekly through a one-hour infusion as per its FDA-approved label. The proposed monthly IV dosing option aims to simplify the treatment regimen for patients and caregivers by extending the intervals between doses following an initial treatment phase.

Leqembi received accelerated FDA approval in January 2023, followed by full approval six months later. Despite these regulatory milestones, the drug's initial rollout in the U.S. faced logistical and diagnostic challenges, which hindered its early uptake. In February, Eisai disclosed that it might not achieve its early adoption targets. According to Keisuke Naito, Eisai’s global Alzheimer's disease officer, the delay was not due to a lack of demand, as approximately 8,000 patients were awaiting access to the therapy at that time.

In addition to the monthly IV dosing effort, Eisai and Biogen are exploring a subcutaneous (under-the-skin) dosing option for Leqembi. This alternative is expected to further enhance patient convenience by allowing at-home treatments, reducing the frequency of hospital visits. Eisai has already initiated the approval process for the subcutaneous form in the U.S., showcasing its commitment to making the treatment more accessible and user-friendly.

Eisai spearheads the development and regulatory submissions for Leqembi on a global scale, while both Eisai and Biogen share the responsibility of co-commercializing the drug. Beyond the U.S., Leqembi has secured approvals in several major markets, including Japan, China, and South Korea. Eisai has also filed for approvals in Europe, Australia, Great Britain, and various other countries, indicating a comprehensive strategy to make the medication widely available.

The recent FDA filing acceptance for the monthly IV maintenance dosing option marks a significant step in Leqembi's journey. If approved, this new dosing regimen could alleviate some of the logistical burdens associated with the current bi-weekly infusions, thereby improving the overall treatment experience for patients and caregivers.

In summary, Eisai and Biogen's efforts to enhance the dosing flexibility of Leqembi demonstrate a proactive approach to addressing patient needs and streamlining treatment processes. With multiple regulatory filings underway and the anticipation of new dosing options, Leqembi is poised to become a more convenient and accessible treatment for Alzheimer's disease patients worldwide.