US FDA approves updated label for TRYVIO, showing benefits outweigh risks

From GlobeNewswire: 2025-04-09 00:55:00

Idorsia Ltd announced that the US FDA has approved an updated label for TRYVIO (aprocitentan), removing the REMS requirement to ensure the benefits outweigh the risks. TRYVIO is a dual endothelin receptor antagonist for systemic hypertension in patients not adequately controlled on other drugs. The Phase 3 PRECISION study showed TRYVIO decreased systolic blood pressure by more than 15 mmHg with good safety. Idorsia will work to make TRYVIO available in retail pharmacies. Aprocitentan is also approved as JERAYGO in the EU and UK. Idorsia aims to challenge medical paradigms and develop transformative medicines. Contact [email protected] for more information.



Read more at GlobeNewswire: US FDA approves an updated label for TRYVIO (aprocitentan)