The US Food and Drug Administration approved baxdrostat (Baxfendy) as the first and only aldosterone synthase inhibitor for the treatment of hypertension in adults whose blood pressure remains uncontrolled despite the use of other antihypertensive medications, according to a press release from AstraZeneca.
The approval was based on findings from the Phase 3 BaxHTN trial, which evaluated baxdrostat in patients with uncontrolled or resistant hypertension receiving at least two antihypertensive agents, including a diuretic. In the 12-week, randomized, placebo-controlled study, 796 patients were assigned to baxdrostat 2 mg, baxdrostat 1 mg, or placebo once daily in addition to standard therapy.
At week 12, patients receiving baxdrostat 2 mg had a 15.7 mmHg reduction in seated systolic blood pressure from baseline, corresponding to a 9.8 mmHg placebo-adjusted reduction. Patients receiving the 1 mg 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 in seated systolic blood pressure. Researchers reported consistent findings in patients with both uncontrolled and resistant hypertension.
Baxdrostat selectively inhibits aldosterone synthase, the enzyme responsible for aldosterone production in the adrenal gland. Elevated aldosterone levels contribute to sodium and water retention and are associated with persistent hypertension, cardiovascular disease, heart failure, and kidney disease. AstraZeneca stated that baxdrostat lowered aldosterone levels without affecting cortisol levels in clinical trials.
Bryan Williams, MD, of University College London and primary investigator of the BaxHTN trial, noted that the “epidemiological data indicate that a 10 mmHg decrease in systolic blood pressure is associated with a roughly 20% lower risk of serious cardiovascular events.”
According to AstraZeneca, approximately half of patients in the US receiving multiple antihypertensive medications continue to have uncontrolled blood pressure. The company stated that baxdrostat is also under investigation in clinical trials evaluating primary aldosteronism, chronic kidney disease, and the prevention of heart failure.
Source: AstraZeneca
