BAXFENDY approved in the US as first-in-class aldosterone synthase inhibitor for hypertension

The US FDA has recently approved AstraZeneca’s BAXFENDY™ (baxdrostat) as the first and only aldosterone synthase inhibitor (ASI) for adults with hypertension whose blood pressure is not adequately controlled on existing therapies. The drug is indicated for use in combination with other antihypertensive medications.

Approval was supported by results from the Phase III BaxHTN trial, in which BAXFENDY produced a statistically significant and clinically meaningful reduction in seated systolic blood pressure at both the 2mg and 1mg doses in patients with uncontrolled or resistant hypertension already taking two or more medications. The 2mg dose lowered systolic blood pressure by 15.7 mmHg from baseline (9.8 mmHg placebo-adjusted). The treatment was generally well-tolerated, with no unanticipated safety findings.

Hypertension affects an estimated 1.4 billion people globally and remains the world’s most prevalent modifiable cardiovascular risk factor, contributing to more deaths and disability than any other. In the US alone, roughly half of patients already on multiple antihypertensive medicines continue to struggle with persistently elevated blood pressure, leaving them at heightened risk of cardiovascular disease and premature death.

BAXFENDY is a highly selective, potent ASI that works through a novel mechanism: it specifically inhibits the production of aldosterone, a hormone that drives blood pressure up and increases the risk of heart and kidney damage. It is the first drug in its class to reach the market.

Dr. Bryan Williams, Chair of Medicine at University College London and BaxHTN primary investigator, 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, 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, BioPharmaceuticals Business Unit, AstraZeneca, 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.”

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Related Topics and Keywords

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