LONDON (dpa-AFX) - AstraZeneca's (AZN) New Drug Application (NDA) for experimental hypertension drug baxdrostat has been granted Priority Review by the U.S. Food and Drug Administration.
The FDA has set a Prescription Drug User Fee Act (PDUFA) date for the second quarter of 2026.
Baxdrostat is designed to inhibit aldosterone synthase, targeting a key hormonal pathway linked to resistant hypertension, a condition that affects roughly half of U.S. patients whose blood pressure remains uncontrolled despite multiple medications. AstraZeneca says the drug could become a first-in-class treatment option.
Sharon Barr, Executive Vice President, BioPharmaceuticals R&D, said: 'This Priority Review demonstrates our commitment to advancing baxdrostat as a potential first- and best-in-class aldosterone synthase inhibitor for the millions of people living with hard-to-control hypertension as quickly as possible. 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.'
The submission is backed by results from the Phase III BaxHTN trial, which showed significant reductions in systolic blood pressure when baxdrostat was added to standard therapy. At 12 weeks, the 2mg dose delivered a placebo-adjusted reduction of 9.8 mmHg, while the 1mg dose achieved an 8.7 mmHg reduction. The drug was generally well-tolerated with mostly mild adverse events.
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