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.
Abbott receives CE Mark for Volt Pulsed Field Ablation System to treat atrial fibrillation
Vast Therapeutics' ALX1 drug candidate granted QIDP designation by US FDA
Qlife secures UK approval to initiate clinical trial for Egoo Phe System
Healthcare Holding Schweiz AG acquires Effectum CH-Rep AG to expand services
Femasys receives CE mark approval for FemBloc delivery system in Europe
Avance Biosciences registers with CLIA program
Abbott announces quarterly common dividend
Aiforia secures IVDR certification for expanded AI-powered cancer diagnostics in Europe
Limaca Medical launches Precision-GI endoscopic automated motorised EUS biopsy device in US
Owens & Minor launches ByramConnect digital health platform for diabetes management
Acrivon Therapeutics receives FDA Breakthrough Device designation for ACR-368 OncoSignature assay
BrainCool secures market approval for BrainCool System in Malaysia
Bioretec Ltd secures CE mark approval for RemeOs Trauma Screw portfolio
Biohit launches FAEX Sample System for stool sample collection