On Tuesday, the U.S. Food and Drug Administration accepted AstraZeneca Plc's (NASDAQ:AZN) New Drug Application (NDA) for baxdrostat for adult patients with hard-to-control (uncontrolled or treatment-resistant) hypertension as an add-on to other antihypertensive medicines.
There are 1.4 billion people worldwide living with hypertension. In the US, approximately 50% of patients living with hypertension on multiple treatments do not have their blood pressure under control.
Aldosterone is increasingly recognised as a key driver of hard-to-control hypertension, contributing to elevated cardiovascular and renal risk.
Data
The NDA is based on data from the BaxHTN Phase 3 trial, which was presented during a Hot Line session at the European Society of Cardiology (ESC) Congress 2025 and 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 SBP were 15.7 mmHg and 9.8 mmHg for the 2mg dose, and 14.5 mmHg and 8.7 mmHg for the 1mg dose, respectively.
SBP, or systolic blood pressure, is the top number in a blood pressure reading that measures the pressure in the arteries when the heart beats.
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.
What Next?
The Prescription Drug User Fee Act (PDUFA) date is anticipated during the second quarter of 2026 following use of a Priority Review voucher.
Baxdrostat is currently being investigated in clinical trials enrolling more than 20,000 patients globally, as a monotherapy for hypertension and primary aldosteronism, and in combination with dapagliflozin for chronic kidney disease and the prevention of heart failure in high-risk patients.
AZN Price Action: AstraZeneca shares were up 0.96% at $91.04 at the time of publication on Wednesday, according to Benzinga Pro data.
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