FDA Approves Aprocitentan for Inadequately Controlled Hypertension

The US Food and Drug Administration has approved aprocitentan (Tryvio) for the treatment of high blood pressure, according to an announcement today from Idorsia Pharmaceuticals, the drug’s manufacturer.

Aprocitentan is a novel endothelin receptor antagonist, the first agent approved in this class, and is indicated for use in patients whose hypertension is currently not controlled on other blood pressure-lowering agents.

The approval is based on the results of PRECISION trial, a study published in the Lancet in 2022 and reported by TCTMD at that time. Patients in the trial had systolic blood pressures of 140 mm Hg or greater despite treatment with three antihypertensive medications, including a diuretic.

After 4 weeks of treatment, doses of 12.5 and 25 mg resulted in an approximate 4-mm Hg reduction in office systolic blood pressure and a 5.0-mm Hg reduction in 24-hour ambulatory systolic blood pressure after adjusting for the change in placebo. These reductions were sustained out to 40 weeks. Edema was the most common side effect during the trial, occurring in 9.1% and 18.4% of patients treated with aprocitentan 12.5 and 25 mg, respectively.

The recommended dose for patients is 12.5 mg once daily, according to the drugmaker’s announcement.

Aprocitentan will be available in the US through a risk evaluation and mitigation strategy (REMS) because the drug can cause major birth defects if used by pregnant patients. It carries a boxed warning for embryo-fetal toxicity, and clinicians must enroll and complete training to be certified prescribers. Pharmacies that dispense aprocitentan must also be certified with the REMS program.