FDA Okays New Drug for Resistant Hypertension

The US Food and Drug Administration (FDA) has approved aprocitentan (Tryvio) to lower blood pressure, in combination with other antihypertensive agents, in adults with treatment-resistant hypertension. 

Aprocitentan is the first endothelin receptor antagonist approved for patients with hypertension. The recommended dose is 12.5 mg orally once daily, with or without food.

The efficacy and safety of aprocitentan were demonstrated in the phase 3 PRECISION study of 730 adults with systolic blood pressure ≥ 140 mmHg who were prescribed at least three antihypertensive medications.

Aprocitentan (12.5 mg daily) was well tolerated and statistically superior to placebo in lowering blood pressure at 4 weeks, with a sustained effect at 40 weeks.

Subgroup analyses showed that the blood pressure–lowering effect of aprocitentan appeared to be consistent among subgroups defined by age, sex, race, body mass index, baseline estimated glomerular filtration rate, baseline urine albumin-to-creatinine ratio, and medical history of diabetes, as well as between blood pressure measurement methods.

‘Transformational Progress’

“We have had to wait for over 30 years to see the approval of an oral anti-hypertensive agent that works on a new therapeutic pathway, so Tryvio provides transformational progress in the field of systemic hypertension,” study investigator Michael A. Weber, MD, State University of New York, commented in a news release. 

“It is taken as a single daily oral dose that works in combination with whatever other drugs are being prescribed and without drug-drug interactions in patients with the burden of uncontrolled hypertension. Tryvio is easy for physicians to prescribe and easy for patients to use,” said Weber. 

Aprocitenan is expected to be available in the second half of this year, the company notes. It will only be available through a Risk Evaluation and Mitigation Strategy (REMS) program owing to the risk for embryo-fetal toxicity. 

Prescribers must be certified with the Tryvio REMS by enrolling and completing training. Pharmacies that dispense the drug must also be certified with the program.