FDA Approves Idorsia’s TRYVIO (aprocitentan) for Hypertension

Highlights:

• Idorsia's TRYVIO (aprocitentan) receives FDA approval for treating hypertension.
• The drug targets patients not adequately controlled on other antihypertensives.
• TRYVIO represents the first oral anti-hypertensive therapy via a new therapeutic pathway approved in almost 40 years.
• Plans are in place to launch TRYVIO in the US in the second half of 2024.

SciFocus/April 16, 2024: Idorsia Pharmaceuticals Ltd (SIX: IDIA) has announced that the US Food and Drug Administration (FDA) has granted approval for TRYVIO? (aprocitentan) to treat hypertension in combination with other antihypertensive drugs, specifically targeting adult patients with uncontrolled blood pressure on other medications. Lowering blood pressure not only mitigates cardiovascular risks but also reduces the incidence of strokes and myocardial infarctions.

Jean-Paul Clozel, MD and Chief Executive Officer of Idorsia, expressed the company's commitment to addressing the significant public health challenge posed by uncontrolled hypertension. He emphasized the importance of TRYVIO as a new treatment option developed by Idorsia's ambitious clinical program.

Key Points:

• TRYVIO (aprocitentan) is the first oral anti-hypertensive therapy using a new therapeutic pathway approved in nearly 40 years.
• Idorsia aims to launch TRYVIO in the US market in the latter half of 2024.
• The drug demonstrated superior efficacy in lowering blood pressure in patients not adequately controlled on other antihypertensives.
• TRYVIO's approval signifies a transformative advancement in systemic hypertension treatment.
• The drug is well-tolerated and effective, even in patients taking multiple antihypertensive medications.

Clinical Insights:

• TRYVIO was evaluated in a Phase 3 study (PRECISION) involving patients with confirmed resistant hypertension.
• The drug showed sustained blood pressure reduction and was superior to placebo, with a favorable safety profile.
• Most common adverse reactions included edema/fluid retention and anemia.
• The approval of TRYVIO marks a significant milestone in Idorsia's research and development efforts in endothelin receptor antagonism.

Future Prospects:

• Idorsia plans to expand research into endothelin receptor antagonists beyond hypertension.
• The company envisions potential applications for aprocitentan in new indications.

The FDA approval of TRYVIO (aprocitentan) represents a breakthrough in hypertension treatment, offering a novel therapeutic option for patients not adequately controlled on existing medications. Idorsia's commitment to innovation in cardiovascular medicine underscores the potential for TRYVIO to improve patient outcomes and contribute to advancing medical science in the field of endothelin receptor antagonism.

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