RADNOR, PA — Idorsia Pharmaceuticals U.S. Inc. has announced the availability of TRYVIO™ (aprocitentan) in the United States for adults suffering from hypertension. This new medication is intended to be used alongside other antihypertensive drugs for patients whose blood pressure remains uncontrolled. Hypertension affects nearly 120 million adults in the U.S., yet only about half of those treated with current therapies achieve target blood pressure levels.
TRYVIO was approved by the FDA following the successful Phase 3 PRECISION trial. The trial showed a significant reduction in systolic blood pressure by 15.4 mm Hg over four weeks when TRYVIO was added to a regimen of at least three other antihypertensive drugs, including a diuretic. The safety profile of TRYVIO was established over 48 weeks, with common side effects including edema and anemia. However, the drug carries a boxed warning for embryo-fetal toxicity.
Tosh Butt, President and General Manager of Idorsia U.S., remarked, “Today, hypertension is the leading modifiable risk factor for cardiovascular disease and mortality in the world. TRYVIO’s availability in the U.S. is an important milestone for the millions of patients who require novel approaches to control their blood pressure.”
Dr. Michael A. Weber, a professor in the Division of Cardiovascular Medicine at the State University of New York, emphasized the drug’s importance: “Uncontrolled hypertension can increase the risk of life-threatening conditions, such as major adverse cardiovascular and cerebrovascular events. TRYVIO provides physicians with a therapeutic option targeting a previously unaddressed pathway.”
TRYVIO is unique as it targets the endothelin system, an important pathway in hypertension’s pathophysiology. It is a 12.5mg oral, once-daily medication, available only through a REMS program to mitigate risks of embryo-fetal toxicity. Prescribers must enroll in this program, though no patient enrollment is needed. TRYVIO can be prescribed exclusively through Walgreens Specialty Pharmacy.
This development offers hope to patients whose hypertension remains uncontrolled with current treatments, providing a new avenue for improving health outcomes in the U.S.
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