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 is a long-term condition in which blood pressure in the arteries stays persistently elevated, usually without symptoms, yet it raises the risk of stroke, heart failure, kidney disease, and dementia. Baxfendy is a tablet that blocks aldosterone synthase, the enzyme the body uses to make aldosterone, a hormone that tells the kidneys to hold onto salt and water. By turning down that hormone signal, the drug may help blood vessels relax and lower blood pressure in adults whose readings remain too high on other medicines.
The purpose of this study is to measure the efficacy and safety of baxdrostat in participants with uHTN or rHTN. The main objective is to compare the difference in SBP change from baseline at Week 12 of treatment between participants receiving 2 mg baxdrostat or 1 mg baxdrostat tablets and participants receiving placebo tablets.
Source: ClinicalTrials.gov