FDA approves an updated label for Tryvio (aprocitentan) removing the REMS requirement- Idorsia

Idorsia announced that the  FDA  after having released Tryvio  (aprocitentan) from its REMS (Risk Evaluation and Mitigation Strategy) requirement (announced on March 17, 2025), has now approved the updated label for Tryvio (aprocitentan). Tryvio is Idorsia’s dual endothelin receptor antagonist (ERA) indicated for the treatment of systemic hypertension in combination with other antihypertensives to lower blood pressure in patients who are not adequately controlled on other drugs. The FDA determined that a REMS was no longer necessary to ensure the benefits of Tryvio outweigh the risk of embryo-fetal toxicity and that labeling is sufficient for conveying the safety information.

Michael Moye, President and General Manager of Idorsia US, commented: “The fact that the FDA has expedited the approval of the updated TRYVIO label to remove the REMS requirements is, I believe, a testament to the importance of Tryvio  As shown in the Phase III PRECISION study, Tryvio decreased systolic blood pressure by more than 15 mmHg from baseline in patients with confirmed resistant hypertensive despite treatment with a combination of antihypertensives. The durable efficacy was achieved with a good safety and tolerability profile. Decreasing BP to such an extent in these high cardiovascular risk patients is known to markedly decrease the risk of fatal and non-fatal cardiovascular events, such as strokes and myocardial infarctions. Idorsia will now work with a sense of urgency to make Tryvio available in retail pharmacies and simplify the administration for prescribers, distributors, and ultimately for patients."