AstraZeneca (NYSE: AZN) announced that the U.S. Food and Drug Administration approved BAXFENDY (baxdrostat) as an aldosterone synthase inhibitor for treating hypertension in adults whose blood pressure remains uncontrolled despite taking multiple antihypertensive medications.

The approval was based on results from the BaxHTN Phase III trial, which showed BAXFENDY 2mg reduced systolic blood pressure by 15.7 mmHg from baseline, with a placebo-adjusted reduction of 9.8 mmHg at week 12. The 1mg dose demonstrated an absolute reduction of 14.5 mmHg and placebo-adjusted reduction of 8.7 mmHg.

BAXFENDY works by inhibiting aldosterone synthase, an enzyme responsible for producing aldosterone, a hormone that raises blood pressure by promoting sodium and water retention. The drug represents what AstraZeneca describes as a first-in-class treatment approach for hypertension.

The BaxHTN trial enrolled 796 patients with uncontrolled or resistant hypertension who were taking two or more antihypertensive medications. Participants were randomized to receive BAXFENDY 2mg, 1mg, or placebo once daily for 12 weeks.

The most frequently reported adverse reactions included hyperkalemia, hypotension, hyponatremia, dizziness, and muscle spasms. The prescribing information includes warnings about hyperkalemia and hyponatremia, requiring monitoring of serum potassium and sodium levels.

The recommended dosage is 2mg orally once daily, with a 1mg dose recommended for patients at increased risk of hyperkalemia or hyponatremia. BAXFENDY is indicated for use in combination with other antihypertensive drugs.

AstraZeneca acquired BAXFENDY through its purchase of CinCor Pharma in February 2023. The company is investigating the drug in additional clinical trials for primary aldosteronism, chronic kidney disease, and heart failure prevention.