Eisai submits supplemental application to FDA for traditional approval of Leqembi

The manufacturer of Leqembi announced it has submitted a supplemental Biologics License Application to the FDA to support the conversion of its recent accelerated approval to a traditional approval.

On Friday, the FDA granted accelerated approval to Eisai for Leqembi (lecanemab-irmb) for the treatment of Alzheimer's disease. Recent data showed the treatment reduced markers of amyloid in early Alzheimer’s and resulted in less decline in cognition and function.

“We are very impressed with our partner Eisai’s diligent work to progress Leqembi with sBLA submission on the same day as the FDA’s accelerated approval,” Gunilla Osswald, CEO of BioArtic, partner of Eisai, said in a released statement. “Alzheimer’s disease is devastating, and the [supplemental Biologics License Application] submission for Leqembi brings us one step closer to a full FDA approval and to potentially being able to offer a new treatment option to millions of patients and their families,”

Eisai said it plans to file for marketing authorization applications in Japan and the European Union by the end of the first quarter of 2023.