AstraZeneca’s Baxfendy (baxdrostat) has been approved in the US as a first-in-class Aldosterone Synthase Inhibitor (ASI) for the treatment of hypertension in combination with other antihypertensive medications, to lower blood pressure in adults who are not adequately controlled.

Baxfendy is a first-in-class, highly selective and potent ASI designed to lower blood pressure in a new way 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.

The approval by the US Food and Drug Administration (FDA) was based on positive results from the BaxHTN phase 3 trial, with Baxfendy demonstrating statistically significant and clinically meaningful seated systolic blood pressure reduction at both 2 mg and 1 mg doses in patients with uncontrolled and resistant hypertension on two or more medications.

Baxfendy was generally well-tolerated with no unanticipated safety findings.

Dr. Bryan Williams, Chair of Medicine, 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 percent lower risk of serious cardiovascular events.”

In the BaxHTN phase 3 trial, published in the New England Journal of Medicine, Baxfendy (baxdrostat) 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 SBP was 15.7 mmHg (95 percent Confidence Interval [CI], -17.6 to -13.7) and placebo-adjusted reduction was 9.8 mmHg (95 percent 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 percent CI, -16.5 to -12.5) and placebo-adjusted reduction was 8.7 mmHg (95 percent CI, -11.5 to -5.8; p<0.001). The reduction in mean seated SBP with placebo was 5.8 mmHg (95 percent CI, -7.9 to -3.8). Results were consistent across both uncontrolled and treatment-resistant subgroups.

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.”