AstraZeneca said on Monday that its hypertension pill baxdrostat had been approved in the United States, providing a new treatment option for millions of patients whose high blood pressure remains uncontrolled despite existing therapies.

The decision allows the drug, marketed under the brand name Baxfendy, to be used in combination with other antihypertensive medicines, News.Az reports, citing Reuters.

AstraZeneca has said it expects Baxfendy to generate more than $5 billion in peak annual sales.

The drug works by lowering blood pressure through inhibition of aldosterone production, a hormone that can raise blood pressure and increase the risk of heart and kidney problems.

This mechanism differs from older hypertension treatments such as diuretics and ACE inhibitors, which do not directly target hormonal drivers of high blood pressure. Baxfendy is also being studied for potential use in chronic kidney disease and heart failure.

The approval places AstraZeneca ahead of US biotech firm Mineralys Therapeutics, which is developing a competing drug, lorundrostat. That drug is currently under US regulatory review, with a decision expected in December.

Hypertension affects around 1.4 billion people globally and is a leading cause of premature death, according to the World Health Organization. In the United States, nearly half of adults—about 120 million people—are estimated to have high blood pressure, based on government data.

The US Food and Drug Administration (FDA) approval is based on results from a late-stage clinical trial in which the drug significantly reduced blood pressure in patients whose hypertension remained uncontrolled or resistant to existing treatments.

In the study, a 2 mg dose of Baxfendy, when added to standard therapy, reduced systolic blood pressure by 9.8 mmHg from baseline after 12 weeks, compared with placebo-adjusted results. At the 1 mg dose, systolic pressure was reduced by 8.7 mmHg, referring to the force exerted by blood against artery walls during heartbeats.

AstraZeneca acquired baxdrostat through its $1.8 billion purchase of CinCor Pharma in February 2023.

News.Az 

By Nijat Babayev