FDA Lifts REMS Requirement for Idorsia’s TRYVIO, Expanding Access

In a significant regulatory milestone, Idorsia announced that the U.S. FDA has fully removed the Risk Evaluation and Mitigation Strategy (REMS) requirement for TRYVIO™ (aprocitentan), a novel dual endothelin receptor antagonist for systemic hypertension. This decision eliminates restrictions and post-marketing study obligations, reflecting the FDA’s confidence in TRYVIO’s safety profile and benefit-risk balance. Designed for patients whose blood pressure remains uncontrolled despite other medications, TRYVIO now offers a more accessible treatment option for those at high cardiovascular risk.

TRYVIO, the first new antihypertensive targeting a novel pathway in over four decades, provides a once-daily, well-tolerated option that can be safely combined with complex drug regimens, including for patients with chronic renal failure. With proven efficacy in significantly lowering systolic blood pressure, Idorsia’s leadership sees this regulatory update as a major step toward broader adoption. “The release of the REMS makes TRYVIO even easier to prescribe,” said Michael Moye, President of Idorsia US. “We are now focused on optimizing its commercial rollout to meet the significant unmet need in hypertension treatment.”