for uncontrolled or resistant hypertension
FDA approved Baxfendy as the first-in-class aldosterone synthase inhibitor (ASI) for the treatment of hypertension in adults whose blood pressure is not adequately controlled on other antihypertensives. Approval establishes the ASI class commercially and creates the competitive bar for Mineralys's lorundrostat (also tracking in this Docket).
Hypertension, or high blood pressure, is a chronic condition where elevated blood pressure increases the risk of serious health problems like heart disease, stroke, and kidney damage. Baxfendy is a first-in-class drug that selectively blocks aldosterone synthase, an enzyme responsible for producing aldosterone, a hormone that regulates blood pressure. By reducing aldosterone levels, Baxfendy may help lower blood pressure in patients who haven’t responded adequately to other treatments.
This is a Phase III, multicentre, randomised, double-blinded, placebo-controlled, parallel group study to evaluate the safety, tolerability and effect of 1 or 2 mg baxdrostat versus placebo, administered once daily (QD) orally, on the reduction of systolic blood pressure in approximately 720 participants aged ≥ 18 years with hypertension, despite a stable regimen of 2 antihypertensive agents at baseline, one of which is a diuretic (uncontrolled hypertension); or ≥ 3 antihypertensive agents at...
Source: ClinicalTrials.gov