BeOne Medicines announces EMA issues positive opinion on Brukinsa tablets

BeOne Medicines (ONC) announced that the Committee for Medicinal Products for Human Use, or CHMP, of the European Medicines Agency, or EMA, issued a positive opinion recommending approval of a new film-coated tablet formulation of BRUKINSA, or zanubrutinib, for all approved indications. The CHMP positive opinion will now be reviewed by the European Commission, which will grant the marketing authorization for the tablet formulation in the European Union and in the European Economic Area countries Norway and Iceland. The BRUKINSA tablets have been shown to be bioequivalent to the BRUKINSA capsules based on the results of two single-dose, open-label, randomized Phase 1 crossover studies in healthy subjects. BeOne Medicines will begin to convert BRUKINSA from capsules to tablets in regions outside China in 2025 as part of our commitment to sustainable business practices, including reducing the impact on the environment.