Swedish research-based biopharma company BioArctic AB (STO:BIOA-B) and its partner Eisai Co Ltd (TYO:4523) announced on Friday that they intend to appeal the negative opinion on lecanemab for Alzheimer's disease from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA).
The companies said that they are disappointed with the decision, which could delay access to the drug for European patients.
Lecanemab is already approved in the United States, Japan, China, South Korea, Hong Kong and Israel, and is currently being marketed in the US, Japan and China.
The drug has demonstrated efficacy in reducing disease progression in clinical trials.
Eisai is responsible for the clinical development, applications for market approval and commercialisation of lecanemab for Alzheimer's disease. BioArctic has the right to commercialise lecanemab in the Nordic region, pending European approval, and currently Eisai and BioArctic are preparing for a joint commercialisation in the region.
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