USFDA approves Idorsia’s Tryvio (Aprocitentan) for Blood Pressure

USFDA has approved Idorsia’s new drug Tryvio, a New Molecular Entity (NME) drug Aprocitentan for treatment of high blood pressure in patients who are not responding well to other medications. However, the approval comes with a black box warning, the most serious warning FDA gives to a drug due to risk of embryo-fetal toxicity (risk of birth defects). Women who are pregnant or plan to become pregnant should not take Tryvio. TRYVIO is available only through a restricted program (REMS) called the TRYVIO REMS. The recommended dosage of Tryvio is once daily oral tablet and it comes in a single strength of 12.5mg tablet

Idorsia announces USFDA approval of TRYVIO (aprocitentan) for treatment of blood pressure