WILMINGTON, Del. — AstraZeneca said the U.S. Food and Drug Administration has approved BAXFENDY as the first aldosterone synthase inhibitor treatment for adults with hypertension whose blood pressure is not adequately controlled.
BAXFENDY, also known as baxdrostat, was approved for use in combination with other antihypertensive medications to lower blood pressure in adults. AstraZeneca said the drug is designed to lower blood pressure by inhibiting production of aldosterone, a hormone that can raise blood pressure and contribute to heart and kidney risks.
The approval was based on results from the Phase III BaxHTN trial, which evaluated BAXFENDY in patients with uncontrolled or resistant hypertension who were already taking two or more medications. AstraZeneca said the drug produced statistically significant and clinically meaningful reductions in seated systolic blood pressure at both the 2-milligram and 1-milligram doses.
At week 12, patients taking the 2-milligram dose had a 15.7 mmHg reduction from baseline in mean seated systolic blood pressure, with a placebo-adjusted reduction of 9.8 mmHg. Patients taking the 1-milligram dose had a 14.5 mmHg reduction from baseline and an 8.7 mmHg placebo-adjusted reduction. The placebo group had a 5.8 mmHg reduction.
AstraZeneca said BAXFENDY was generally well tolerated, with no unanticipated safety findings.
“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,” said Bryan Williams, chair of medicine at University College London and primary investigator of the BaxHTN trial.
Hypertension affects about 1.4 billion people worldwide. AstraZeneca said approximately half of U.S. patients with hypertension who are already taking multiple antihypertensive medications continue to have persistently elevated blood pressure.
“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,” said John M. Clymer, executive director of the National Forum for Heart Disease & Stroke Prevention.
Ruud Dobber, executive vice president of AstraZeneca’s BioPharmaceuticals Business Unit, said the approval gives patients a new option after years of limited therapeutic progress in hypertension.
“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,” Dobber said.
Results from the BaxHTN Phase III trial were published in the New England Journal of Medicine. The company said the blood pressure reductions were consistent across both uncontrolled and treatment-resistant hypertension subgroups.
