FDA accepts Eisai's monthly dosing application for Leqembi, sets Jan. 25 decision date

Shortly after Eisai initiated a rolling FDA application for a subcutaneous form of Leqembi, another of the company's regulatory efforts on the Alzheimer's disease medicine is progressing. 

The FDA has accepted the company's application for a monthly intravenous maintenance dosing option, according to a Monday release. The agency is expected to decide on the filing by January 25, 2025.

As it stands, the drug is administered every two weeks in a one-hour infusion, according to the Leqembi FDA label. The new dosing option would offer patients and caregivers added convenience by stretching dosing intervals to once per month after a treatment initiation phase.

After Leqembi's accelerated approval in January 2023 and its full approval six months later, the drug has been somewhat hampered by logistics and diagnostics hurdles early in its U.S. rollout. In February, Eisai revealed that it was likely to miss an early uptake target.

The slower-than-expected start was not for a lack of demand: Some 8,000 patients were waiting to access the therapy at the time, Keisuke Naito, Eisai’s global Alzheimer’s disease officer, explained on a February conference call.

Besides the monthly intravenous dosing effort, Eisai and Biogen hope the introduction of a subcutaneous dosing option will further boost convenience by allowing for at-home treatment. Eisai recently began approval efforts for that dosing option in the U.S.

Eisai is leading development and regulatory submissions for Leqembi worldwide, while the company and Biogen are co-commercializing the medicine. 

Outside the U.S., the drug is approved in Japan, China and South Korea. Eisai has submitted approval filings in Europe, Australia, Great Britain and several other countries.

Editor's note: This story has been corrected to note that Monday's FDA filing acceptance is for the monthly intravenous maintenance dosing option.