Ad hoc announcement pursuant to Art. 53 LR Idorsia receives a positive opinion from the Committee for Medicinal Products for Human Use for JERAYGO„ (aprocitentan) as the first and only endothelin...
US FDA approves Idorsia`s once-daily TRYVIO (aprocitentan)
RADNOR, Pa., March 20, 2024 /PRNewswire/ -- Idorsia Pharmaceuticals U.S. Inc. announced today that the US Food and Drug Administration (FDA) has approved TRYVIO™ (aprocitentan) for the treatment of hypertension in combination with other antihypertensive drugs, to lower blood pressure in adult patients who are not adequately controlled on other drugs.1 Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions.1 The recommended dosage of TRYVIO is 12.5 mg orally once daily, with or without food.1
Idorsia has lost Johnson & Johnson's Janssen Biotech unit as the partner for its aprocitentan candidate for resistant hypertension, following a likely delay in the FDA's review of the drug.
Allschwil, Switzerland June 26, 2023 Idorsia Ltd (SIX: IDIA) today announced that further data for aprocitentan, Idorsia™s investigational dual endothelin receptor antagonist evaluating the...
Idorsia submits a New Drug Application to the US FDA for aprocitentan for the treatment of patients with difficult-to-control hypertension
ZURICH, Dec 20 (Reuters) - Swiss biotech company Idorsia has submitted a new application for approval of the drug aprocitentan to the U.S. Food and Drug Administration.
Idorsia Ltd (SIX: IDIA) today announced the publication of “A randomized controlled trial of the dual endothelin antagonist aprocitentan for resistant hypertension” in The Lancet. The publication reports the results from the Phase 3 PRECISION study, which found aprocitentan, Idorsia’s investigational, novel dual endothelin receptor antagonist, significantly reduced blood pressure (BP) and maintained the effect for up to 48 weeks when added to combination background antihypertensive therapy in patients with difficult-to-control (resistant) hypertension. In parallel, these data were presented by Prof. Markus Schlaich, an investigator in PRECISION, as a Late-Breaking Science presentation during the American Heart Association (AHA) Scientific Sessions 2022.
An investor/analyst webcast and conference call will be held to discuss the results of the Phase 3 PRECISION study of aprocitentan for patients with resistant hypertension. These results are being presented as a late-breaking science presentation during the American Heart Association (AHA) Scientific Sessions 2022.
The topline results confirm Idorsia’s hypothesis that endothelin is the “missing link” for patients whose hypertension can’t be controlled by existing therapies, according to CSO Martine Clozel. By its estimate, by 2025 that group could total 10 million in the US alone.