The United States has approved the first and only aldosterone synthase inhibitor for the treatment of hypertension in adults, GxP News reports.
The US Food and Drug Administration has approved AstraZeneca’s Baxfendy (baxdrostat) as a first‑in‑class aldosterone synthase inhibitor for the treatment of hypertension. The drug is intended for use in combination with other antihypertensive medicines to lower blood pressure in adults whose blood pressure is not adequately controlled.
Worldwide, 1.4 billion people suffer from hypertension. In the United States, approximately 50% of patients being treated for the condition still experience persistently high blood pressure – a leading risk factor for cardiovascular disease and premature death.
Baxfendy is a first‑in‑class, highly selective and potent aldosterone inhibitor designed to lower blood pressure through a novel mechanism – by specifically suppressing production of aldosterone, a hormone that raises blood pressure to unhealthy levels and increases the risk of heart and kidney disease.
The FDA approval is based on positive Phase III clinical trial results in which Baxfendy showed statistically significant and clinically meaningful reductions in seated systolic blood pressure at both 2 mg and 1 mg doses in patients with uncontrolled and resistant hypertension who were taking two or more antihypertensive drugs.
AstraZeneca’s drug was well tolerated, with no safety concerns identified during its use.
“The new way of lowering blood pressure could potentially change clinical practice by targeting the root cause of persistently uncontrolled hypertension,” said Dr. Bryan Williams, chair of medicine at University College London. “Epidemiological data show that reducing systolic blood pressure by 10 mmHg reduces the risk of major cardiovascular events by about 20%.”
Ruud Dobber, executive vice president of AstraZeneca’s Biopharmaceuticals Business Unit, noted that approximately 23 million patients in the United States suffer from uncontrolled hypertension despite taking two or more medications for the condition.
