Overview
- The FDA cleared AstraZeneca’s Baxfendy on Monday for use with other drugs in adults whose high blood pressure stays uncontrolled or is treatment‑resistant.
- The medicine targets aldosterone synthase, the enzyme that makes the hormone aldosterone, which raises blood pressure by causing the body to hold salt and water.
- In the phase 3 BaxHTN trial, systolic blood pressure fell by about 10 mm Hg with the 2 mg dose and about 9 mm Hg with the 1 mg dose after 12 weeks versus placebo.
- The label recommends 2 mg once daily, or 1 mg for patients at higher risk of electrolyte issues, with regular blood tests for potassium and sodium because hyperkalemia was the most common side effect.
- AstraZeneca says U.S. pharmacies will have the drug next month, and the approval puts it ahead of Mineralys’ rival lorundrostat, which is awaiting an FDA decision in December.