The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for Dupixent® (dupilumab), recommending expanded approval in the European Union (EU) to treat severe atopic dermatitis in children 6 months to 5 years old who are candidates for systemic therapy.
BioArctic AB's (publ) (Nasdaq Stockholm: BIOA B) partner Eisai announced today that the European Medicines Agency (EMA) has accepted a marketing authorization application (MAA) for lecanemab (Brand Name in the U.S.: LEQEMBI™), an investigational anti-amyloid beta (Aβ) protofibril antibody[1], for the treatment of Early Alzheimer's disease (mild cognitive impairment due to Alzheimer's disease (AD)