(RTTNews) - Idorsia Ltd (IDRSF. OB) announced that the US Food & Drug Administration, after having released TRYVIO from its Risk Evaluation and Mitigation Strategy or REMS requirement, has now approved the updated label for TRYVIO (aprocitentan).
TRYVIO is Idorsia's dual endothelin receptor antagonist (ERA) indicated for the treatment of systemic hypertension in combination with other antihypertensives to lower blood pressure in patients who are not adequately controlled on other drugs.
The 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.
TRYVIO is commercially available through Walgreens Specialty Pharmacy.
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