WILMINGTON, DE — AstraZeneca received U.S. regulatory approval for BAXFENDY (baxdrostat), a new treatment for adults with uncontrolled hypertension, marking the first new drug class for the condition in years and potentially expanding options for millions of patients whose blood pressure remains elevated despite multiple medications.
The U.S. Food and Drug Administration approved BAXFENDY for use in combination with other antihypertensive therapies to lower blood pressure in adults who are not adequately controlled on existing treatments.
The approval is based on results from the Phase III BaxHTN trial, which showed statistically significant reductions in systolic blood pressure among patients with uncontrolled or treatment-resistant hypertension already receiving at least two medications.
At 12 weeks, patients receiving the 2-milligram dose experienced an average systolic blood pressure reduction of 15.7 mmHg from baseline, compared with a 5.8 mmHg reduction in the placebo group. The placebo-adjusted reduction was 9.8 mmHg. Patients receiving the 1-milligram dose achieved a placebo-adjusted reduction of 8.7 mmHg.
Results from the study were published in the New England Journal of Medicine.
BAXFENDY is an aldosterone synthase inhibitor, a new class of medicine designed to lower blood pressure by blocking production of aldosterone, a hormone associated with elevated blood pressure and increased cardiovascular and kidney risks.
“We have been waiting for an innovative medication like BAXFENDY for hypertension for many years,” said Dr. Bryan Williams, chair of medicine at University College London and the trial’s primary investigator. “Its novel way of lowering blood pressure has the potential to transform clinical practice by targeting a root cause of persistently uncontrolled hypertension.”
Williams added that a reduction of approximately 10 mmHg in systolic blood pressure has been associated with roughly a 20% reduction in the risk of serious cardiovascular events.
Hypertension remains one of the most prevalent cardiovascular risk factors globally. According to data cited by AstraZeneca, approximately 1.4 billion people worldwide live with the condition. In the United States, about half of patients already taking multiple blood pressure medications continue to struggle with uncontrolled hypertension.
Ruud Dobber, executive vice president of AstraZeneca’s BioPharmaceuticals Business Unit, said roughly 23 million U.S. patients remain uncontrolled despite treatment with two or more medications.
“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,” Dobber said.
John M. Clymer, executive director of the National Forum for Heart Disease & Stroke Prevention, said additional treatment options could help address a condition linked to stroke, heart attack, kidney disease, and dementia.
“Hypertension remains a staggeringly widespread silent killer,” Clymer said. “Tens of millions of people struggle to control their blood pressure despite lifestyle changes and currently available treatments.”
AstraZeneca said BAXFENDY was generally well tolerated during clinical testing, with no unexpected safety findings reported in the Phase III trial.
The approval introduces the first aldosterone synthase inhibitor available in the United States and gives physicians a new therapeutic approach for managing patients whose blood pressure remains uncontrolled despite standard treatment.
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