04:26 AM EDT, 05/15/2024 (MT Newswires) -- Biogen (BIIB) and Eisai said Tuesday that the latter has initiated a rolling submission of a biologics license application to the US Food and Drug Administration for lecanemab-irmb subcutaneous autoinjector as a weekly maintenance treatment for early Alzheimer's disease.

The application came after the treatment, commercially known as Leqembi, was granted FDA fast-track designation, the company said.

Leqembi is approved in the US, Japan, and China, with applications under review in the European Union, Australia, Brazil, Canada and Hong Kong, among others.

Eisai leads lecanemab's development and regulatory submissions while sharing commercialization marketing duties with Biogen.

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