Therapy Areas: Devices
BioArctic reports EMA acceptance of MAA for lecanemab in early Alzheimer's disease
27 January 2023 -

Swedish research-based biopharma company BioArctic AB (STO:BIOA-B) reported on Friday that the European Medicines Agency (EMA) has accepted a marketing authorisation application (MAA) submitted by its partner Eisai Co Ltd (TYO:4523) for an investigational treatment for early Alzheimer's disease.

The MAA for lecanemab (known as Leqembi in the US) is for the treatment of early Alzheimer's disease (mild cognitive impairment due to Alzheimer's disease (AD) and mild AD dementia) with confirmed amyloid pathology. In conjunction with EMA's acceptance of the file, BioArctic is entitled to a milestone payment of EUR5m.

In the United States, lecanemab was granted accelerated approval as a treatment for AD by the Food and Drug Administration (FDA) on 6 January 2023. Eisai submitted a Supplemental Biologics License Application (sBLA) to the FDA for approval under the traditional pathway on the same day. In Japan, Eisai submitted an MAA to the Pharmaceuticals and Medical Devices Agency (PMDA) on 16 January 2023. In China, Eisai initiated submission of data for a BLA to the National Medical Products Administration (NMPA) of China in December 2022.

Under the agreement between BioArctic and Eisai, the Japanese company serves as the lead of lecanemab development and regulatory submissions globally with both Eisai and Biogen co-commercialising and co-promoting the product and Eisai having final decision-making authority. BioArctic has right to commercialise lecanemab in the Nordic market under certain conditions and is currently preparing for commercialisation in the Nordics together with Eisai.



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