Posted by Michael Wonder on 26 Jun 2025
BeOne Medicines receives positive CHMP opinion for tablet formulation of Brukinsa
25 June 2025 - BeOne Medicines today announced that the CHMP of the EMA issued a positive opinion recommending approval of a new film coated tablet formulation of Brukinsa (zanubrutinib) for all approved indications.
The Brukinsa tablets have been shown to be bio-equivalent to the Brukinsa capsules based on the results of two single-dose, open-label, randomised Phase 1 cross-over studies in healthy subjects.
