AstraZeneca (LSE:AZN) announced it has secured US Food and Drug Administration approval for Baxfendy (baxdrostat), an aldosterone synthase inhibitor to lower blood pressure in adults, whose hypertension is not adequately controlled on other antihypertensive medicines.
The approval rests on the 796‑patient BaxHTN Phase III trial in which once‑daily Baxfendy 2mg reduced mean seated systolic blood pressure by 15.7 mmHg from baseline and by 9.8 mmHg versus placebo at week 12, and results were published in the New England Journal of Medicine, AstraZeneca said.
"The nearly double‑digit placebo‑adjusted systolic blood pressure reduction achieved with Baxfendy is exciting and clinically meaningful for clinicians and patients," Dr Bryan Williams, BaxHTN primary investigator, said.
Baxfendy was generally well tolerated with no unanticipated safety findings in BaxHTN, the drug company said.
AstraZeneca acquired the asset through its purchase of CinCor Pharma in February 2023 and says the programme will continue with trials in primary aldosteronism, combinations in chronic kidney disease, and heart‑failure prevention.
The FDA clearance opens the US market for an estimated 23 million adults the company says remain uncontrolled despite taking two or more antihypertensive medicines, it highlighted.
