Baxfendy approved in the US for hypertension treatment
Baxfendy was approved in the US for hypertension in adults not adequately controlled on other antihypertensive medicines. The approval was based on Phase III BaxHTN results showing significant systolic blood pressure reductions.
Baxfendy (baxdrostat) has been approved in the US as a first-in-class aldosterone synthase inhibitor for the treatment of hypertension in combination with other antihypertensive medications, to lower blood pressure in adults who are not adequately controlled. The approval by the US Food and Drug Administration was based on positive results from the BaxHTN Phase III trial, with Baxfendy demonstrating statistically significant and clinically meaningful seated systolic blood pressure reduction at both 2mg and 1mg doses in patients with uncontrolled and resistant hypertension on two or more medications.
Baxfendy was generally well-tolerated with no unanticipated safety findings. In the BaxHTN Phase III trial, published in the New England Journal of Medicine, Baxfendy demonstrated statistically significant and clinically meaningful efficacy for the treatment of patients with hypertension on top of standard of care.
At week 12, the absolute reduction from baseline in mean seated systolic blood pressure was 15.7 mmHg (95% confidence interval [CI], -17.6 to -13.7) and placebo-adjusted reduction was 9.8 mmHg (95% CI, -12.6 to -7.0; p<0.001) for the 2mg dose. For the 1mg dose, the absolute reduction from baseline was 14.5 mmHg (95% CI, -16.5 to -12.5) and placebo-adjusted reduction was 8.7 mmHg (95% CI, -11.5 to -5.8; p<0.001). The reduction in mean seated systolic blood pressure with placebo was 5.8 mmHg (95% CI, -7.9 to -3.8). Results were consistent across both uncontrolled and treatment-resistant subgroups.
Baxfendy is a first-in-class, highly selective and potent aldosterone synthase inhibitor designed to lower blood pressure by specifically inhibiting the production of aldosterone, a hormone that raises blood pressure to unhealthy levels and increases the risk of heart and kidney problems. There are 1.4 billion people worldwide living with hypertension. In the US, approximately 50% of patients living with hypertension who are already taking multiple antihypertensive medications still struggle with persistently elevated blood pressure.
BAXFENDY can cause hyperkalemia. Assess serum potassium prior to initiation of BAXFENDY and monitor periodically during treatment. Correct serum potassium abnormalities prior to initiation.