Shots:
- The US FDA has accepted NDA & granted priority review to Baxdrostat as an add-on treatment of pts with uncontrolled or treatment-resistant hypertension (PDUFA: Q2’26 following use of PRV)
- NDA was supported by the P-III (BaxHTN) trial assessing baxdrostat (1 or 2mg, QD, PO) vs PBO on top of SoCs in 796 pts with uncontrolled or treatment-resistant hypertension over 12wks.
- Trial met its 1EP, reducing mean seated SBP at 12wks. by 15.7 (2mg) & 14.5 mmHg (1mg), with PBO-adjusted decrease of 9.8 (2mg) & 8.7 (1mg); effects were consistent across subgroups. Results were presented at ESC’25 & published in The NEJM
Ref: AstraZeneca | Image: AstraZeneca | Press Release
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