AstraZeneca (AZN.L) secured FDA approval for blood pressure drug Baxfendy

AstraZeneca received U.S. approval for hypertension treatment Baxfendy, giving the drugmaker a new entrant into the large and highly competitive cardiovascular market.

The therapy, also known as baxdrostat, was approved for use alongside existing blood pressure medications in patients with uncontrolled hypertension despite current treatments.

Baxfendy works by blocking production of aldosterone, a hormone linked to elevated blood pressure and increased risks of heart and kidney disease. The mechanism differs from older blood pressure treatments such as diuretics and ACE inhibitors, which do not directly target hormonal drivers of hypertension.

The approval was based on late-stage trial data showing the therapy significantly reduced systolic blood pressure in patients with resistant hypertension when added to standard treatment.

AstraZeneca has projected more than $5 billion in peak annual sales for Baxfendy, highlighting the company’s commercial expectations for the drug. The therapy is also being studied for chronic kidney disease and heart failure, potentially expanding its long-term market opportunity.

The approval also placed AstraZeneca ahead of Mineralys Therapeutics, which is developing rival hypertension therapy lorundrostat and is awaiting a U.S. regulatory decision later this year.

Hypertension affects an estimated 1.4 billion people globally and remains one of the leading causes of premature death worldwide, according to the World Health Organization.