USFDA Approves AstraZeneca's Baxfendy for Uncontrolled Hypertension
London: Anglo-Swedish drugmaker AstraZeneca said on Monday its hypertension pill baxdrostat had been approved in the United States, offering a new treatment option for millions of patients with uncontrolled high blood pressure despite existing medicines.
The decision allows use of the drug, branded as Baxfendy, in combination with other antihypertensive medicines. AstraZeneca has said it expects Baxfendy to generate more than $5 billion in peak annual sales.
The drug is designed to lower blood pressure by inhibiting production of aldosterone, a hormone that can raise blood pressure and increase the risk of heart and kidney problems.
This approach is different from older blood pressure treatments like diuretics and ACE inhibitors, which do not address hormonal drivers. Baxfendy is also being studied as a possible treatment for chronic kidney disease and heart failure.
The approval puts AstraZeneca ahead of U.S. biotech Mineralys Therapeutics, which is developing a rival drug, lorundrostat. Mineralys' drug is under U.S. review with a regulatory decision expected in December.
Hypertension affects about 1.4 billion people worldwide and is a major cause of premature death, according latest estimates by the World Health Organization. In the U.S., nearly half of all adults or about 120 million people have high blood pressure, according to government data.
FDA's decision is based on data from a late-stage study, in which the drug significantly reduced blood pressure in patients whose hypertension was uncontrolled or resistant despite existing medicines.
In that trial, a 2 mg dose of Baxfendy, added to standard treatment, reduced systolic blood pressure by 9.8 millimetres of mercury (mmHg) from the baseline at 12 weeks after adjusting for placebo. At the 1 mg dose, that pressure exerted on the arteries by the heart's pumping action was lowered by 8.7 mmHg.
AstraZeneca acquired the drug as part of its $1.8 billion acquisition of CinCor Pharma in February 2023.
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