AstraZeneca’s Baxfendy approved by US FDA for adults with uncontrolled hypertension
AstraZeneca’s Baxfendy (Baxdrostat) has been approved by the US FDA as a first-in-class aldosterone synthase inhibitor (ASI) to treat 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.
Clinical Efficacy and Safety
The approval 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 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.
Addressing a Global Crisis
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, which is a leading risk factor for cardiovascular disease and premature death.Hypertension is the most prevalent and significant modifiable cardiovascular risk factor worldwide, accounting for more deaths and disability than any other modifiable risk.
Bryan Williams, Chair of Medicine at University College London and BaxHTN primary investigator, said: “Baxfendy’s 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% lower risk of serious cardiovascular events.”
Ruud Dobber, Executive Vice President, BioPharmaceuticals Business Unit at 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.”
