Biopharmaceutical company AstraZeneca plc (LSE: AZN) (STO: AZN) (NYSE: AZN) reported on Monday that it has received US Food and Drug Administration approval for Baxfendy (baxdrostat), the first and only aldosterone synthase inhibitor for the treatment of hypertension in adults whose blood pressure is not adequately controlled on existing therapies.

This approval is based on results from the BaxHTN Phase III trial, which demonstrated statistically significant and clinically meaningful reductions in systolic blood pressure. At the 2mg dose, Baxfendy reduced seated systolic blood pressure by 15.7 mmHg from baseline and by 9.8 mmHg compared with placebo at week 12.

The trial included patients with uncontrolled or resistant hypertension and showed consistent efficacy across both subgroups. The 1mg dose also demonstrated meaningful reductions, with a placebo-adjusted reduction of 8.7 mmHg.

AstraZeneca said Baxfendy works by inhibiting aldosterone production, a hormone linked to elevated blood pressure and increased cardiovascular and renal risk. The company highlighted hypertension as a major global health burden affecting an estimated 1.4 billion people worldwide.

Safety results from the Phase III programme showed the treatment was generally well tolerated with no unexpected findings.

The approval strengthens AstraZeneca's cardiovascular, renal and metabolism portfolio, which remains a key growth area for the group's broader biopharmaceutical strategy.