Idorsia’s TRYVIO Cleared for Wider Use After FDA Label Update

Idorsia Ltd (SIX: IDIA) announced today that the U.S. Food and Drug Administration (FDA) has approved an updated label for TRYVIO™ (aprocitentan), following the recent removal of its REMS (Risk Evaluation and Mitigation Strategy) requirement. The decision means TRYVIO, Idorsia’s dual endothelin receptor antagonist, is now cleared for broader use in treating systemic hypertension when used in combination with other blood pressure-lowering medications. This update simplifies access and reflects the FDA’s assessment that the product’s safety profile is now well addressed through labeling alone—specifically regarding the previously required safeguards around embryo-fetal toxicity.

Michael Moye, President and General Manager of Idorsia US, emphasized the significance of the FDA’s swift action: “This expedited label update is a clear recognition of TRYVIO’s clinical importance. In the Phase 3 PRECISION study, TRYVIO reduced systolic blood pressure by more than 15 mmHg in patients whose hypertension remained uncontrolled despite being on a combination of antihypertensives. These results are not only impressive but clinically meaningful, as such reductions are known to significantly lower the risk of serious cardiovascular events, including heart attacks and strokes.”

He added, “With this milestone, we’re moving quickly to make TRYVIO available in retail pharmacies and streamline its use for prescribers and patients alike.”