The Food and Drug Administration has approved a first-of-its-kind hypertension treatment that could become AstraZeneca’s next blockbuster product.
A once-daily tablet, Baxfendy is now cleared, in combination with other antihypertensive drugs, to lower blood pressure for adults whose condition isn’t adequately controlled. The FDA based its decision on a late-stage trial that had results published in the New England Journal of Medicine last summer.
The trial enrolled patients whose blood pressure remained hard to control blood despite the use of multiple therapies. Results showed that two different doses of Baxfendy were each significantly better than a placebo at reducing “seated blood pressure” — the standard measurement clinicans use to diagnose hypertension. The drug was also generally well tolerated, with most adverse events classified as mild. Of those, the most common were muscle spasms, dizziness, too-low blood pressure and abnormal levels of sodium and potassium in the blood.
Baxfendy doesn’t work like existing medications. It instead inhibits an enzyme that synthesizes “aldosterone,” a hormone which causes blood pressure to rise by telling the body to excrete potassium while retaining water and salt. AstraZeneca saw enough promise in this approach to acquire Baxfendy’s developer, CinCor Pharma.
