Idorsia’s Tryvio Targets Unmet Needs in Hypertension, Pioneering a New Treatment Pathway
Idorsia’s development of aprocitentan was specifically geared towards tackling this challenge, with a dedicated clinical program aimed at addressing the needs of patients who continue to experience high blood pressure despite receiving multiple antihypertensive medications at optimal doses. This strategic approach reflects Idorsia’s commitment to advancing the field of resistant hypertension management and improving outcomes for patients facing this medical dilemma.
Hypertension stands as a primary contributor to cardiovascular disease, affecting approximately 10% of the estimated 1.3 billion individuals with hypertension globally. Among them, a significant portion grapples with difficult-to-control hypertension even with the use of multiple medications.
Until the approval of Tryvio, there existed no FDA-approved systemic antihypertensive therapies targeting the ET pathway. Current treatment options for resistant hypertension primarily focus on regulating salt and water, antagonizing the renin–angiotensin–aldosterone system, reducing extracellular calcium influx into cells, sympatholytic activity, or non-selective vasodilatory effects.
FDA Clears Tryvio After PRECISION Trial: A Milestone for Resistant Hypertension Care
The FDA’s decision to approve Tryvio was based on data from the Phase III PRECISION trial, which evaluated the short- and long-term efficacy of Tryvio in 730 patients with difficult-to-control hypertension across a three-part study. During the trial, Tryvio consistently demonstrated reductions in sitting systolic blood pressure (SBP) compared to placebo, meeting both primary and secondary efficacy endpoints.
Furthermore, Tryvio exhibited consistent efficacy across various patient subgroups, including sex, age, body mass index, race, and geographic area. Treatment-emergent adverse events (AEs) were reported in a higher percentage of patients administered Tryvio compared to placebo, with mild-to-moderate fluid retention being the most frequently observed AE.
PRECISION trial investigator Michael A. Weber, MD, highlighted the significance of Tryvio’s approval in addressing the unmet need for effective resistant hypertension management in high-risk patients. He emphasized the transformative progress offered by Tryvio, marking the first oral antihypertensive agent in over three decades to target a new therapeutic pathway. Tryvio’s once-daily oral dosing regimen, coupled with its compatibility with other prescribed medications and minimal drug-drug interactions, presents a promising option for both physicians and patients grappling with uncontrolled hypertension.
Resource: Pharmexec, March 20, 2024
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