Health
Baxdrostat New Drug Application accepted under FDA Priority Review in the US for patients with hard-to-control hypertension
WILMINGTON, Del., December 02, 2025--AstraZeneca’s New Drug Application (NDA) for baxdrostat has been accepted for Priority Review by the US Food and Drug Administration (FDA) in the US for the treatment of adult patients with hard-to-control (uncontrolled or treatment resistant) hypertension as an add-on to other antihypertensive medicines when these do not provide adequate lowering of blood pressure.
About this update from Astrazeneca Plc
[{"type":"image","alt":"","displaySize":"","headline":null,"caption":"","credit":null,"className":"","disableSlideshowImg":false,"size":{"original":{"width":1181,"height":286,"url":"https://media.zenfs.com/en/business-wire.com/7c86290948b21171b1288275094bedf0"},"resized":{"url":"https://s.yimg.com/ny/api/res/1.2/FFYcmWBcGowd7PvT2HHp3Q--/YXBwaWQ9aGlnaGxhbmRlcjt3PTk2MDtoPTIzMjtjZj13ZWJw/https://media.zenfs.com/en/business-wire.com/7c86290948b21171b1288275094bedf0","width":960,"height":232},"lightbox":{"url":"https://s.yimg.com/ny/api/res/1.2/Vhgf6kQRUWRtk1YGAyjwGA--/YXBwaWQ9aGlnaGxhbmRlcjt3PTIzNjI7aD01NzI7Y2Y9d2VicA--/https://media.zenfs.com/en/business-wire.com/7c86290948b21171b1288275094bedf0","width":1181,"height":286}},"lazy":false},{"type":"text","content":"Submission based on positive BaxHTN Phase III trial results which demonstrated statistically significant and clinically meaningful reduction in systolic blood pressure in patients with resistant or uncontrolled hypertension","length":223,"tagName":"p","attribs":{}},{"type":"text","content":"If approved, baxdrostat could be the first aldosterone synthase inhibitor to receive regulatory authorization","length":109,"tagName":"p","attribs":{}},{"type":"text","content":"WILMINGTON, Del., December 02, 2025--(BUSINESS WIRE)--AstraZeneca’s New Drug Application (NDA) for baxdrostat has been accepted for Priority Review by the US Food and Drug Administration (FDA) in the US for the treatment of adult patients with hard-to-control (uncontrolled or treatment resistant) hypertension as an add-on to other antihypertensive medicines when these do not provide adequate lowering of blood pressure.","length":422,"tagName":"p"},{"type":"text","content":"The Prescription Drug User Fee Act (PDUFA) date is anticipated during the second quarter of 2026 following use of a Priority Review voucher.","length":140,"tagName":"p"},{"type":"text","content":"There are 1.4 billion people worldwide living with hypertension.1 In the US, approximately 50% of patients living with hypertension on multiple treatments do not have their blood pressure under control.2 Aldosterone is increasingly recognized as a key driver of hard-to-control hypertension, contributing to elevated cardiovascular and renal risk.3,4","length":350,"tagName":"p"},{"type":"text","content":"Sharon Barr, Executive Vice President, BioPharmaceuticals R&D, said: &qu...