AstraZeneca’s Baxfendy (baxdrostat) has been approved in the US as an aldosterone synthase inhibitor for use in combination with other antihypertensive drugs to lower blood pressure in adults whose hypertension is not adequately controlled. The decision is based on results from the Phase III BaxHTN trial, in which Baxfendy showed statistically significant and clinically meaningful reductions in systolic blood pressure in patients with uncontrolled or resistant hypertension on at least two medications.
In BaxHTN, Baxfendy 2mg reduced seated systolic blood pressure (SBP) by 15.7 mmHg from baseline, corresponding to a placebo‑adjusted reduction of 9.8 mmHg at 12 weeks. The 1mg dose reduced SBP by 14.5 mmHg, with a placebo‑adjusted reduction of 8.7 mmHg, while the placebo arm showed a 5.8 mmHg reduction. Baxfendy was generally well tolerated, and no unanticipated safety findings were reported. Results were consistent in both uncontrolled and treatment‑resistant subgroups and have been published in the New England Journal of Medicine.
Baxfendy is described as a highly selective and potent aldosterone synthase inhibitor designed to lower blood pressure by inhibiting production of aldosterone, a hormone that raises blood pressure and is linked to increased risks of heart and kidney problems. Hypertension affects 1.4 billion people globally; in the US, about half of patients with hypertension who are already on multiple therapies continue to have persistently elevated blood pressure, a major risk factor for cardiovascular disease and premature death.
Bryan Williams, MD, Chair of Medicine at University College London and primary investigator for BaxHTN, said Baxfendy’s mechanism targets a driver of persistently uncontrolled hypertension and noted that the nearly double‑digit placebo‑adjusted SBP reduction is clinically meaningful. He highlighted epidemiologic data suggesting that a 10 mmHg reduction in systolic blood pressure is associated with about a 20% lower risk of serious cardiovascular events.
John M. Clymer, Executive Director of the National Forum for Heart Disease & Stroke Prevention, called hypertension a “silent killer” and a leading risk factor for stroke, heart attack, kidney damage and dementia. He said many people struggle to control blood pressure despite lifestyle measures and existing therapies, and that new treatments could help protect heart, kidney and brain health.
Ruud Dobber, Executive Vice President, BioPharmaceuticals Business Unit at AstraZeneca, said the approval addresses patients with persistently uncontrolled hypertension who have not responded to or tolerated current options. He noted that in the US an estimated 23 million patients remain uncontrolled despite being on two or more antihypertensive medicines, in a disease area that has seen limited therapeutic change in recent decades.
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