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.
DATROWAY receives US priority review for first-line metastatic triple negative breast cancer
Lupin launches Dasatinib tablets in US market
Natera submits Signatera CDx PMA to FDA for bladder cancer use
Pharming receives FDA complete response letter for paediatric Joenja application
Trace Biosciences' IND application for nerve-specific imaging agent approved by FDA
Frontage expands early phase clinical research capabilities across US and China
MicuRx Pharmaceuticals' IND application for MRX-5 cleared by FDA
FDA approves Tenpoint Therapeutics' YUVEZZI as first dual-agent eye drop for presbyopia
Summit Therapeutics' BLA for ivonescimab in EGFR-mutated NSCLC accepted by FDA
WuXi Biologics collaborates with Sinorda Biomedicine for antibody development
Biogen's litifilimab receives FDA Breakthrough Therapy Designation for CLE
Glaukos receives FDA approval for repeat administration of iDose TR
Guerbet's contrast agent Elucirem approved by European Commission in children from birth
Spine Innovation's LOGIC Titanium Implant System receives US FDA 510(k) market approval