AstraZeneca's Baxfendy (baxdrostat) has been recommended for European Union approval to treat adults whose arterial hypertension remains insufficiently controlled with at least two antihypertensive medicines. If approved, it would become the EU's first aldosterone synthase inhibitor, targeting production of a hormone involved in elevated blood pressure.
The European Medicines Agency's Committee for Medicinal Products for Human Use based its positive opinion on two pivotal Phase 3 trials, BaxHTN and Bax24, evaluating patients with uncontrolled or resistant hypertension. Both studies assessed treatment added to standard care, measuring seated systolic blood pressure in BaxHTN and average ambulatory systolic blood pressure over 24 hours in Bax24.
BaxHTN randomized 796 patients to receive Baxfendy 2 mg, 1 mg or placebo once daily; at week 12, the 2 mg dose reduced mean seated systolic blood pressure by 15.7 mmHg from baseline, a placebo-adjusted reduction of 9.8 mmHg (p<0.001). Bax24 randomized 218 patients with resistant hypertension to Baxfendy 2 mg or placebo, with the active treatment reducing average ambulatory systolic blood pressure by 16.6 mmHg from baseline at week 12, a placebo-adjusted reduction of 14.0 mmHg (p<0.0001).
In Bax24, 70.6% of treated patients achieved average ambulatory systolic blood pressure below 130 mmHg, compared with 16.7% receiving placebo. AstraZeneca reported that Baxfendy was generally well tolerated across the trials, with no unanticipated safety findings.
Baxfendy is approved in the United States and other countries for adults whose hypertension is inadequately controlled on other therapies. Regulatory applications remain under review in Japan and China.
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