AstraZeneca’s new drug application (NDA) for baxdrostat has been accepted for priority review by the US Food and Drug Administration (FDA) for the treatment of adult patients with hard-to-control (uncontrolled or treatment resistant) hypertension as an add-on to other antihypertensive medicines when these do not provide adequate lowering of blood pressure.
The NDA is based on data from the BaxHTN Phase III trial which was presented during a hot line session at the 2025 European Society of Cardiology (ESC) congress (29 August–1 September, Madrid, Spain) and also simultaneously published in the New England Journal of Medicine.
The trial showed that baxdrostat, on top of standard of care, met the primary and all secondary endpoints. Standard of care consisted of a stable regimen of two antihypertensive agents at baseline, one of which is a diuretic (uncontrolled hypertension) or more than three antihypertensive agents at baseline, one of which is a diuretic (treatment-resistant hypertension).
At week 12, the change from baseline and placebo-adjusted change from baseline reductions in mean seated systolic blood pressure (SBP) were 15.7mmHg and 9.8mmHg for the 2mg dose, and 14.5mmHg and 8.7mmHg for the 1mg dose, respectively. The results were consistent across both uncontrolled and treatment-resistant subgroups.
Baxdrostat was generally well tolerated with a safety profile consistent with its mechanism of action. There were no unanticipated safety findings, and most adverse events were mild.
