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The US Food and Drug Administration (FDA) has granted approval for aprocitentan (Tryvio), marking a significant milestone in hypertension management. Aprocitentan, the first endothelin receptor antagonist approved for patients with treatment-resistant hypertension, offers a promising new treatment option for adults struggling to control their blood pressure.
Administered orally at a recommended dose of 12.5 mg once daily, with or without food, aprocitentan is designed to complement existing antihypertensive therapies. Its approval follows successful results from the phase 3 PRECISION study, which evaluated its efficacy and safety in 730 adults with systolic blood pressure ≥ 140 mmHg who were already taking at least three antihypertensive medications.
The study demonstrated that aprocitentan effectively lowered blood pressure, with sustained efficacy observed over a 40-week period. Notably, subgroup analyses revealed consistent efficacy across various patient demographics and clinical characteristics, indicating its broad applicability in diverse populations.
Commenting on the approval, study investigator Michael A. Weber, MD, from the State University of New York, hailed aprocitentan as a groundbreaking advancement in hypertension management. After more than three decades of anticipation, the approval of Tryvio represents a transformative breakthrough in systemic hypertension treatment. Weber emphasized the drug’s ease of use, noting its single daily oral dose and compatibility with existing medication regimens, without the risk of drug interactions.
However, due to the potential risk of embryo-fetal toxicity, aprocitentan will only be available through a Risk Evaluation and Mitigation Strategy (REMS) program. Prescribers and pharmacies must be certified with the Tryvio REMS by enrolling and completing training before dispensing the drug to patients.
Aprocitentan is expected to become available in the second half of this year, offering hope to individuals grappling with treatment-resistant hypertension. With its approval, aprocitentan represents a significant step forward in addressing unmet needs in hypertension management and improving outcomes for patients with this challenging condition.
