FDA removes REMS requirement from Idorsia’s Tryvio label

Swiss biopharma Idorsia (SIX: IDIA) has received approval from the US Food and Drug Administration for an updated label on its hypertension drug Tryvio (aprocitentan), removing the previous Risk Evaluation and Mitigation Strategy requirement.

The decision comes less than a month after the agency ruled that the safety labeling alone was sufficient to address concerns around embryo-fetal toxicity. Tryvio, a dual endothelin receptor antagonist, is used in combination with other antihypertensive treatments to lower blood pressure.

The updated label reflects the FDA’s conclusion that additional restrictions are no longer necessary to ensure safe use of the medicine, which is indicated for patients with systemic hypertension who are not adequately controlled on other therapies.