USFDAMay 18, 2026, 09:47 AM
AstraZeneca's Baxfendy Approved in US for Hypertension
AI Summary
AstraZeneca announced that its drug Baxfendy (baxdrostat) has received US FDA approval as a first-in-class aldosterone synthase inhibitor for treating hypertension in adults whose blood pressure is not adequately controlled by other medications. The approval is based on positive BaxHTN Phase III trial results, which demonstrated statistically significant and clinically meaningful reductions in systolic blood pressure. This new treatment offers a novel approach to lowering blood pressure by inhibiting aldosterone production, addressing a significant unmet need for millions of patients.
Key Highlights
- Baxfendy approved in the US as the first-in-class aldosterone synthase inhibitor for hypertension.
- Approval based on positive BaxHTN Phase III trial results.
- Baxfendy 2mg lowered systolic blood pressure by 15.7 mmHg (9.8 mmHg placebo-adjusted) from baseline.
- Baxfendy 1mg lowered systolic blood pressure by 14.5 mmHg (8.7 mmHg placebo-adjusted) from baseline.
- Approximately 23 million US patients are uncontrolled despite being on two or more hypertension medicines.
- A 10 mmHg decrease in systolic blood pressure is associated with a roughly 20% lower risk of serious cardiovascular events.
- AstraZeneca acquired Baxfendy through its purchase of CinCor Pharma, Inc. in February 2023.
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