Baxdrostat New Drug Application accepted under FDA Priority Review in the US for patients with hard-to-control hypertension
View original at finance.yahoo.comBaxdrostat New Drug Application accepted under FDA Priority Review in the US for patients with hard-to-control hypertension 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 o…
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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
80% confidenceThe 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
80% confidenceIf approved, baxdrostat could be the first aldosterone synthase inhibitor to receive regulatory authorization
80% confidenceBaxdrostat was generally well tolerated with a safety profile consistent with its mechanism of action. There were no unanticipated safety findings, and most adverse events were mild
80% confidence
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