FDA Considers Monthly Dosing for Alzheimer’s Drug Leqembi

The FDA has accepted Eisai’s application for a monthly intravenous maintenance dosing option, as per the announcement. The agency is expected to make a decision by January 25, 2025. If approved, these indications give the FDA permission to assign a monthly dosing schedule to Alzheimer’s drug Leqembi.

Eisai highlighted that the FDA has approved its NDA submission for the monthly intravenous maintenance dosing regimen as stated in the release.

After starting a rolling FDA application for a subcutaneous form of Leqembi, Eisai is progressing on another regulatory front for the Alzheimer’s asset.

These instructions are currently mentioned on the FDA label as follows – Leqembi is to be administered every two weeks in a one-hour infusion. The new dosing option, if approved in the United States, would allow for use just once a month after the initial treatment phase.

While Leqembi received accelerated approval in January 2023 and then full approval in July 2023, the distribution has faced several logistic and diagnostic issues in the United States. Eisai highlighted in February that it expected to be off course on early adoption by a few percentage points.

The initially slower-than-expected rate of growth was not because the market did not want it. About 8,000 patients are still awaiting this therapy, said Keisuke Naito, Eisai’s head for the global and commercial business of Alzheimer’s disease in a conference call in February.

Besides the monthly IV administration method, Eisai and Biogen are focusing on developing an SC administration method, which can be even more convenient if patients can self-administer it at home. This option has not yet been approved by the regulatory authorities in the U.S., however, Eisai recently started the process.

Leqembi is being developed and submitted for approval by regulatory authorities in major world markets by Eisai and co-promoted by Biogen. Internationally, Leqembi is approved in Japan, China and South Korea, apart from the US. It has also applied for the approval of its drugs in Europe, Australia, Great Britain, and other countries.

Leqembi (lecanemab-irmb) is a humanized immunoglobulin gamma 1 monoclonal antibody- it is not a preventative vaccine.

In the United States, the drug is applicable for use in managing Alzheimer’s disease in patients who have initial signs of dementia or deterioration in their cognitive ability.

As a part of the monthly IV maintenance, the patients who completed the biweekly IV initiation cycle with the duration currently under FDA consideration would then go on to receive the IV solution monthly. This dosage is intended to maintain the necessary drugs’ levels and constant elimination of highly toxic amyloid beta (Aβ) protofibrils that could damage neurons.

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