The FDA has given AstraZeneca approval for its aldosterone synthase inhibitor (ASI), Baxfendy (baxdrostat), to treat adults with uncontrolled or resistant hypertension who are taking at least two medications.
Baxfendy is a first-in-class, highly-selective, potent ASI that inhibits the production of aldosterone. By limiting the hormone, it prevents high blood pressure at the same time as lowering the risk for heart and kidney problems.
In the phase 3 BaxHTN clinical trial, 2 mg of the oral drug reduced systolic blood pressure by 15.7 mmHg from baseline, compared to a reduction of 9.8 mmHg with a placebo. In patients taking 1 mg, the reduction was 14.5 mmHg, compared to a placebo-adjusted reduction of 8.7 mmHg. Both of these results were statistically significant and clinically meaningful. Results were consistent whether patients were in the uncontrolled or treatment-resistant subgroup. The drug was also well tolerated, resulting in no unanticipated safety findings.
In addition to this clinical trial, AstraZeneca is currently investigating Baxfendy in clinical trials as a monotherapy for hypertension and primary aldosteronism, a hormonal disorder. It is also investigating the drug in combination with Farxiga for chronic kidney disease and the prevention of heart failure in high-risk hypertensive patients.