The U.S. Food and Drug Administration (FDA) has approved baxdrostat, a new drug developed by the Anglo-Swedish pharmaceutical giant AstraZeneca. The medication, which will be marketed under the brand name Baxfendy, introduces a brand-new treatment paradigm for millions of patients whose high blood pressure could not be controlled by existing therapies.
Under the FDA’s decision, the new drug is authorized for use in combination with other antihypertensive medications. AstraZeneca forecasts that peak annual sales for Baxfendy will exceed $5 billion.
How Does the New Drug Work?
The mechanism of action for Baxfendy differs radically from older-generation antihypertensive agents (such as diuretics or ACE inhibitors), which do not target the underlying hormonal causes of the disease. The new medication lowers blood pressure by blocking the production of the hormone aldosterone. It is this specific hormone that drives blood pressure elevation in the body and increases the risk of heart and kidney damage. Clinical trials are currently underway to evaluate the drug’s efficacy in treating chronic kidney disease (CKD) and heart failure as well.
The FDA’s decision is backed by data from Phase III clinical trials, where the medication significantly reduced blood pressure in patients whose hypertension had previously been resistant to other drugs. The study demonstrated that when added to standard therapy over a 12-week period, a 2 mg dose of Baxfendy reduced systolic (top number) blood pressure by an average of 9.8 mmHg, while a 1 mg dose lowered it by 8.7 mmHg.
With this approval, AstraZeneca has outpaced the American biotech firm Mineralys Therapeutics, which is developing a competing drug in the same class (lorundrostat). The FDA’s decision regarding that treatment is expected in December of this year.
A Global Challenge
According to the latest data from the World Health Organization (WHO), arterial hypertension affects approximately 1.4 billion people globally and remains a leading cause of premature mortality. In the United States, high blood pressure affects nearly half of the adult population—amounting to nearly 120 million people. The formula for this innovative drug came under AstraZeneca’s ownership after the company acquired CinCor Pharma for $1.8 billion in February 2023.
