AstraZeneca has secured US approval for Baxfendy, a first‑in‑class aldosterone synthase inhibitor for adults whose hypertension remains uncontrolled despite treatment with other antihypertensive medicines.
The decision is based on positive phase 3 BaxHTN results showing statistically significant and clinically meaningful reductions in systolic blood pressure.
Hypertension affects 1.4 billion people worldwide, with around half of US patients continuing to experience elevated blood pressure even while taking multiple therapies. AstraZeneca noted that hypertension remains the most prevalent modifiable cardiovascular risk factor globally, contributing to deaths and disability.
Baxfendy is designed to inhibit aldosterone production, a hormone that raises blood pressure and increases cardiovascular and renal risk.
In the phase 3 BaxHTN trial, the 2mg dose reduced systolic blood pressure by 15.7 mmHg from baseline, equivalent to a placebo‑adjusted reduction of 9.8 mmHg. The 1mg dose achieved a 14.5 mmHg reduction, or 8.7 mmHg placebo‑adjusted. Baxfendy was generally well tolerated with no unanticipated safety findings.
Dr Bryan Williams, primary investigator for BaxHTN, said: “We have been waiting for an innovative medication like Baxfendy for hypertension for many years. Its novel way of lowering blood pressure has the potential to transform clinical practice by targeting a root cause of persistently uncontrolled hypertension.
“In addition, the nearly double-digit placebo-adjusted systolic blood pressure reduction achieved with Baxfendy is exciting and clinically meaningful for clinicians and patients. Epidemiological data indicate that a 10 mmHg decrease in systolic blood pressure is associated with a roughly 20% lower risk of serious cardiovascular events.”
John M Clymer, Executive Director of the National Forum for Heart Disease & Stroke Prevention, said: “Hypertension remains a staggeringly widespread silent killer and a leading risk factor for stroke, heart attack, kidney damage and dementia. Tens of millions of people struggle to control their blood pressure despite lifestyle changes and currently available treatments. Innovative, new treatments could help millions protect their heart, kidney and brain health.”
Ruud Dobber, Executive Vice President of AstraZeneca’s BioPharmaceuticals Business Unit, said: “The approval of Baxfendy offers a much needed, first-in-class innovation for people living with persistently uncontrolled hypertension who have not responded to or tolerated existing medicines.
“In the US, about 23 million patients are uncontrolled despite being on two or more medicines for hypertension, which is a disease that has seen little therapeutic progress for the past two decades.”
