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FDA Approves AstraZeneca’s Baxfendy for Hard-to-Control Hypertension

The oral aldosterone‑blocking pill showed near double‑digit drops in systolic pressure in late‑stage testing.

Overview

  • AstraZeneca’s Baxfendy, which won U.S. approval Monday, can be prescribed with other blood‑pressure drugs for patients whose readings stay high despite treatment.
  • In a late‑stage study, 2 mg lowered systolic pressure by 9.8 mmHg at 12 weeks after placebo adjustment, and 1 mg lowered it by 8.7 mmHg.
  • The medicine blocks aldosterone, a hormone that raises blood pressure by driving salt and water retention, so it can complement diuretics and ACE inhibitors.
  • The approval puts AstraZeneca ahead of Mineralys Therapeutics, whose rival aldosterone inhibitor lorundrostat is under FDA review with a decision expected in December.
  • AstraZeneca projects more than $5 billion in peak annual sales as hypertension affects about 1.4 billion people worldwide and roughly 120 million U.S. adults.