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# FDA OKs Dropping Tryvio REMS
- URL: https://www.fdaweb.com/fda-oks-dropping-tryvio-rems/
- Published: 2025-04-09T12:00:00.000Z
- Updated: 2026-09-14T14:57:21.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5158975

FDA has approved updated labeling for Idorsia’s Tryvio (aprocitentan) that eliminates the Risk Evaluation and Mitigation Strategy (REMS) requirement. A company [statement](https://www.globenewswire.com/news-release/2025/04/09/3058096/0/en/US-FDA-approves-an-updated-label-for-TRYVIO-aprocitentan-removing-the-REMS-requirement.html?ref=fdaweb.com) says Tryvio is a dual endothelin receptor antagonist indicated for treating systemic hypertension in combination with other antihypertensives to lower blood pressure in patients who are not adequately controlled on other drugs.

“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,” the statement says.