AstraZeneca (NASDAQ: AZN) announced that the U.S. Food and Drug Administration has approved Baxfendy (baxdrostat) for treating hypertension in adults whose blood pressure remains inadequately controlled despite taking other antihypertensive medications.

Baxfendy represents the first aldosterone synthase inhibitor approved for hypertension treatment. The drug works by inhibiting aldosterone production, a hormone that elevates blood pressure and increases cardiovascular and kidney risks.

The FDA approval was based on results from the BaxHTN Phase III trial, published in the New England Journal of Medicine. The study demonstrated that Baxfendy achieved statistically significant blood pressure reductions in patients with uncontrolled and resistant hypertension taking two or more medications.

In the trial, the 2mg dose showed a placebo-adjusted reduction of 9.8 mmHg in seated systolic blood pressure at 12 weeks, while the 1mg dose achieved an 8.7 mmHg placebo-adjusted reduction. Both results were statistically significant with p-values less than 0.001.

According to the company, approximately 50% of U.S. patients with hypertension who take multiple antihypertensive medications continue to experience elevated blood pressure. The company stated that about 23 million U.S. patients remain uncontrolled despite taking two or more hypertension medications.

The drug was generally well-tolerated in the clinical trial with no unexpected safety findings, according to the study results.

Hypertension affects 1.4 billion people worldwide and serves as a leading risk factor for cardiovascular disease and premature death.