Baxdrostat New Drug Application accepted under FDA Priority Review in the US for patients with hard-to-control hypertension

Core Insights - AstraZeneca's New Drug Application (NDA) for baxdrostat has been accepted for Priority Review by the FDA for treating hard-to-control hypertension, potentially making it the first aldosterone synthase inhibitor to receive regulatory approval [1][3][4] Group 1: Drug Efficacy and Clinical Trials - The NDA submission is based on positive results from the BaxHTN Phase III trial, which showed a statistically significant reduction in systolic blood pressure in patients with resistant or uncontrolled hypertension [1][4] - In the BaxHTN trial, the 2mg dose of baxdrostat resulted in a mean seated systolic blood pressure reduction of 15.7 mmHg, while the 1mg dose showed a reduction of 14.5 mmHg, both statistically significant [4][11] - The trial included 796 patients and demonstrated efficacy across both uncontrolled and treatment-resistant hypertension subgroups [4][11] Group 2: Market Context and Need - Approximately 1.4 billion people globally suffer from hypertension, with about 50% of U.S. patients on multiple treatments not achieving adequate blood pressure control [2][9] - Aldosterone is identified as a key factor in hard-to-control hypertension, contributing to increased cardiovascular and renal risks [2][10] Group 3: Safety and Tolerability - Baxdrostat was generally well tolerated, with a safety profile consistent with its mechanism of action, and most adverse events reported were mild [5][6] Group 4: Future Prospects - The Prescription Drug User Fee Act (PDUFA) date for baxdrostat is anticipated in the second quarter of 2026, following the use of a Priority Review voucher [2] - AstraZeneca is investigating baxdrostat in clinical trials involving over 20,000 patients globally, both as a monotherapy and in combination therapies for hypertension and chronic kidney disease [6][7]