Drugs

AstraZeneca Gets OK for New Hypertension Drug

FDA has approved AstraZeneca’s Baxfendy (baxdrostat), making it the first aldosterone synthase inhibitor in the U.S. for adults with hypertension whose blood pressure remains uncontrolled despite treatment with other medicines. The approval marks the first new mechanism for treating hypertension in roughly two decades and targets patients whose blood pressure remains elevated despite taking multiple antihypertensive drugs, according to the company.

The FDA approval was based on results from the Phase 3 BaxHTN trial, in which Baxfendy demonstrated statistically significant reductions in systolic blood pressure in patients with uncontrolled or resistant hypertension taking at least two background therapies, including a diuretic.

According to the company, patients receiving the 2 mg dose experienced a 15.7 mmHg reduction in systolic blood pressure from baseline after 12 weeks, compared with a placebo-adjusted reduction of 9.8 mmHg. Patients receiving the 1 mg dose saw an absolute reduction from baseline of 14.5 mmHg and the placebo-adjusted reduction was 8.7 mmHg. AstraZeneca cited epidemiological data showing that a 10 mmHg reduction in systolic blood pressure is associated with about a 20% lower risk of major cardiovascular events.

Baxfendy is designed to selectively inhibit aldosterone synthase, an enzyme involved in aldosterone production, without affecting cortisol levels. Elevated aldosterone has been associated with resistant hypertension and progression of heart and kidney disease.

AstraZeneca said the drug was generally well-tolerated, with no unexpected safety findings reported during the study.

The company is also studying baxdrostat in additional cardiovascular and kidney-related conditions, including primary aldosteronism, chronic kidney disease and heart failure prevention.

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