The Food and Drug Administration has given the green light to a new blood pressure medication that could help millions of Americans struggling with uncontrolled hypertension, the Anglo-Swedish pharmaceutical company AstraZeneca announced Monday.
The newly approved medication, called Baxfendy, represents a fresh approach for patients whose high blood pressure remains problematic even while taking current medications. Federal regulators have authorized its use alongside other blood pressure treatments.
Company officials project the medication could bring in over $5 billion in yearly revenue at its peak sales period.
Unlike traditional blood pressure medications such as water pills and ACE inhibitors, Baxfendy works by blocking the creation of aldosterone, a hormone that can elevate blood pressure and heighten the chances of heart and kidney complications. This hormonal targeting represents a departure from older treatment methods that don’t tackle these underlying hormone issues.
Researchers are also investigating whether Baxfendy could treat chronic kidney disease and heart failure conditions.
The approval gives AstraZeneca a competitive edge over U.S. biotech company Mineralys Therapeutics, which is working on a competing medication called lorundrostat. Federal regulators are currently reviewing Mineralys’ drug, with a decision anticipated in December.
According to World Health Organization statistics, approximately 1.4 billion people globally suffer from high blood pressure, making it a leading contributor to early death. Government figures show nearly half of American adults – roughly 120 million people – deal with elevated blood pressure.
Federal drug officials based their approval on results from an advanced clinical trial where the medication substantially lowered blood pressure in patients whose condition remained uncontrolled or resistant to existing treatments.
During the study, participants taking a 2 mg dose of Baxfendy along with standard care saw their systolic blood pressure drop by 9.8 millimetres of mercury from starting levels after 12 weeks, when compared to those receiving a placebo. The 1 mg dose reduced the pressure created by the heart’s pumping action by 8.7 mmHg.
AstraZeneca obtained the medication through its $1.8 billion purchase of CinCor Pharma in February 2023.
