FDA approves baxdrostat for the treatment of adults with uncontrolled hypertension
Baxdrostat has been approved by the FDA for the treatment of adults with uncontrolled hypertension.
The U.S. Food and Drug Administration (FDA) has approved baxdrostat for the treatment of adults with inadequately controlled hypertension in combination with other antihypertensive therapies. Baxdrostat is the first approved aldosterone synthase inhibitor, introducing a new mechanism of action for blood pressure lowering in patients with difficult-to-control hypertension. The approval was based on positive results from the phase 3 BaxHTN trial.
BaxHTN was a multicenter, randomized, double-blinded, placebo-controlled, parallel group trial in which 796 patients with uncontrolled hypertension (treated with at least two antihypertensive medications) or treatment-resistant hypertension (treated with at least three antihypertensive medications) were randomized in a 1:1:1 ratio to baxdrostat 2 mg, 1 mg or placebo once daily, on top of standard of care.
In the study, baxdrostat significantly reduced SBP compared with placebo after 12 weeks of treatment. Patients receiving the 2 mg dose achieved a placebo-adjusted reduction in mean seated SBP of 9.8 mmHg (95%CI: -12.6 to -7.0; P<0.001), while the 1 mg dose achieved a placebo-adjusted reduction of 8.7 mmHg (95%CI: -11.5 to -5.8; P<0.001). The results were consistent in both the subgroup with uncontrolled hypertension and the subgroup with treatment-resistant hypertension.
Baxdrostat was generally well tolerated, with no unexpected safety signals observed.