AstraZeneca's Baxfendy wins EU panel backing for uncontrolled hypertension
AZN•The European Medicines Agency’s human medicines committee recommended Baxfendy for EU approval for adults whose hypertension is not controlled by at least two blood pressure medicines. If approved, it would be the EU’s first and only aldosterone synthase inhibitor.
1. EU panel recommendation
AstraZeneca’s Baxfendy (baxdrostat) received a recommendation for European Union approval from the European Medicines Agency’s human medicines committee. The recommendation covers adults whose hypertension is insufficiently controlled by at least two blood pressure medicines.
2. Trial results and safety
Published Phase III results from the BaxHTN and Bax24 trials showed meaningful blood pressure reductions in patients with uncontrolled or resistant hypertension. Baxfendy was generally well tolerated, with no unexpected safety findings, and is already approved in the U.S. and other countries.
