FDA Drops REMS Requirement for Antihypertensive Aprocitentan

The US Food and Drug Administration will no longer require aprocitentan (Tryvio), a novel endothelin receptor antagonist, to be part of its drug safety program, according to an announcement from manufacturer Idorsia Pharmaceuticals.

Approved last year for patients with hypertension currently not controlled on other blood pressure-lowering agents, the drug previously was only available in the US through the FDA’s risk evaluation and mitigation strategy (REMS). Medications with serious safety concerns are subject to the REMS program so the agency can ensure that the benefits of treatment outweigh potential risks.

The REMS requirements were initially mandated given safety concerns about embryo-fetal toxicity if aprocitentan was used in pregnant women, but the updated label is now sufficient to convey the safety information, according to Wednesday’s announcement.

The 2024 approval of aprocitentan was based on the results of the 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, treatment with aprocitentan 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.