FDA accepts baxdrostat NDA for priority review
AstraZeneca’s (LSE: AZN) New Drug Application (NDA) for baxdrostat has been accepted for Priority Review by the US Food and Drug Administration (FDA) in the USA 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.
The Prescription Drug User Fee Act (PDUFA) date is anticipated during the second quarter of 2026 following use of a Priority Review voucher, the UK pharma major noted.
AstraZeneca gained baxdrostat through its $1.3 billion acquisition of CinCor Pharma in 2023.
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