The US Food and Drug Administration (FDA) has accepted the application for marketing authorization of Leqembi (lecanemab-irmb) as a weekly maintenance subcutaneous autoinjector treatment, filed by Eisai, partner of Bioarctic. This is what a press release states.
The application is based on the open extension portion of the Clarity AD study and modeling based on the data collected.
“If Leqembi subcutaneous maintenance therapy is approved by the FDA, Leqembi will be the only Alzheimer’s disease treatment that can be administered subcutaneously at home using an auto-injector.” , writes Bioarctic.
The final decision date (PDUFA) is set for August 31 this year.
-Leqembi is already approved in the United States for the treatment of mild cognitive impairment and mild Alzheimer’s disease.
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