AstraZeneca (AZN.L, AZN.ST) secured priority review from the US Food and Drug Administration for its hypertension therapy, baxdrostat, accelerating the evaluation process for the drug targeting patients with hard-to-control high blood pressure.
The pharmaceutical giant said Tuesday that the drug is indicated as an add-on treatment for uncontrolled or treatment-resistant hypertension, adding that baxdrostat is poised to become the first-in-class aldosterone synthase inhibitor to receive regulatory approval. Its Prescription Drug User Fee Act decision date is expected in the second quarter of 2026.
The application is based on positive readout from the BaxHTN late-stage trial, which showed statistically significant and clinically meaningful reduction in systolic blood pressure in patients with hard-to-control hypertension. Baxdrostat achieved all its primary and secondary endpoints in the 12-week double-blind, placebo-controlled study and was generally well-tolerated, with results consistent across uncontrolled and treatment-resistant subgroups.
"The substantial reduction in systolic blood pressure seen in the BaxHTN trial underscores baxdrostat's novel mechanism of action and its potential to bring innovation to a disease area that has seen limited progress in over two decades," BioPharmaceuticals R&D Executive Vice President Sharon Barr said.
AstraZeneca noted that hypertension affects 1.4 billion people globally. In the US, 50% of patients already on multiple treatments still have uncontrolled blood pressure.
Baxdrostat is being broadly investigated, with clinical trials enrolling over 20,000 patients globally. The program includes testing the drug as a monotherapy for hypertension and primary aldosteronism, and in combination with dapagliflozin for chronic kidney disease and heart failure prevention in high-risk patients.
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