FDA Greenlights Novel Hypertension Pill for Tough-to-Treat Patients

The FDA approved the first-in-class oral aldosterone synthase inhibitor baxdrostat (Baxfendy) to treat adults with uncontrolled hypertension in combination with other antihypertensive drugs, AstraZeneca announced.

Aldosterone can raise blood pressure by stimulating retention of sodium and water and is a key contributor to persistently uncontrolled hypertension. Baxdrostat has high selectivity for aldosterone synthase, suppressing hormone synthesis rather than blocking the mineralocorticoid receptor and reducing off-target effects.

The decision was based on results from the phase III BaxHTN trial, which showed that adding baxdrostat improved systolic blood pressure in adults on at least two antihypertensive medications for uncontrolled or resistant hypertension.

From baseline to 12 weeks, seated systolic blood pressure dropped a mean 14.5 mm Hg with a 1-mg once-daily dose of baxdrostat and 15.7 mm Hg with a 2-mg dose, as compared with a 5.8 mm Hg decrease for placebo recipients (P<0.001 for both comparisons). At that point, 39-40% of the baxdrostat group achieved systolic blood pressure control to under 130 mm Hg versus 18.7% of the placebo group.

“[Baxdrostat’s] novel way of lowering blood pressure has the potential to transform clinical practice by targeting a root cause of persistently uncontrolled hypertension,” investigator Bryan Williams, MD, of University College London, said in a statement. “Epidemiological data indicate that a 10 mm Hg decrease in systolic blood pressure is associated with a roughly 20% lower risk of serious cardiovascular events.”

The most common adverse event in the trial was hyperkalemia.

Oral baxdrostat’s recommended dose is 2 mg daily, though for patients at increased risk of hyponatremia or hyperkalemia the recommended dose is 1 mg daily. Patients taking baxdrostat should have their serum potassium and sodium assessed before starting the drug and periodically during use.

Providers should also monitor for interactions with drugs that increase serum potassium and with strong and moderate CYP3A inducers.

AstraZeneca said baxdrostat will be available in pharmacies next month.