The US Food and Drug Administration (FDA) has fully released TRYVIO™ (aprocitentan) from its Risk Evaluation and Mitigation Strategy (REMS) requirement, effective immediately, Idorsia Ltd announced on March 17, 2025. This regulatory decision significantly reduces administrative burdens for healthcare providers and potentially expands access to this novel antihypertensive medication.
The FDA determined that a REMS is no longer necessary to ensure the benefits of TRYVIO outweigh the risk of embryo-fetal toxicity, concluding that standard labeling is sufficient for conveying safety information. This decision follows an evaluation of human fetal outcomes after exposure to drugs in the endothelin receptor antagonist (ERA) class.
As a result of this change, prescribers and pharmacists are no longer required to interact with the REMS program when prescribing or dispensing TRYVIO. Additionally, Idorsia has been released from its post-marketing requirement to conduct a worldwide descriptive study collecting data on women exposed to TRYVIO during pregnancy and/or lactation.
A Novel Approach to Treating Resistant Hypertension
TRYVIO represents the first new antihypertensive medication with a novel mechanism of action in over 40 years. As a dual endothelin receptor antagonist, it targets the endothelin pathway, which plays a significant role in blood pressure regulation but had not been previously addressed by antihypertensive medications.
"This change is very important considering that TRYVIO can be prescribed to a large patient population, who have a high cardiovascular risk and whose hypertension could not be brought under control with the previous classes of medication," said Martine Clozel, Chief Scientific Officer of Idorsia.
TRYVIO is indicated for the treatment of systemic hypertension in combination with other antihypertensives to lower blood pressure in patients who are not adequately controlled on other drugs. Clinical data has shown that when added to existing antihypertensive regimens, aprocitentan can decrease systolic blood pressure by more than 15 mmHg from baseline at trough.
Clinical Advantages and Patient Benefits
The medication offers several important clinical advantages that make it particularly valuable for patients with difficult-to-control hypertension:
- Once-daily oral tablet formulation
- No clinically relevant drug interactions, allowing safe combination with complex drug regimens
- Can be used by chronic renal failure patients with hypertension without dose modification
- Well-tolerated over the long term
Michael Moye, President and General Manager of Idorsia US, emphasized the significance of the REMS removal: "The release of the REMS is fantastic news as it makes TRYVIO even easier to prescribe. TRYVIO is available to prescribe today, and we are now looking for the best commercial solution to fully launch this important medication that fills a large unmet patient need."
Regulatory Status and Availability
TRYVIO has been commercially available in the United States since October 2024. Idorsia will submit revised labeling to the US FDA in accordance with the release of the REMS in the coming weeks.
The medication continues to be commercially available through Walgreens Specialty Pharmacy. In Europe and the UK, aprocitentan is approved under the brand name JERAYGO™ for the treatment of resistant hypertension in combination with other antihypertensives. Marketing authorization applications are currently under review in Canada and Switzerland.
Hypertension Management Challenges
Hypertension affects approximately 1.28 billion adults worldwide and is a leading risk factor for cardiovascular disease. Despite the availability of multiple antihypertensive drug classes, a significant proportion of patients fail to achieve adequate blood pressure control with standard therapies.
Resistant hypertension, defined as blood pressure that remains above goal despite the use of three or more antihypertensive agents of different classes, represents a particular challenge in clinical practice. These patients face significantly higher risks of cardiovascular events, including stroke, heart attack, and heart failure.
The introduction of TRYVIO, with its novel mechanism of action and the removal of REMS requirements, provides an important new option for clinicians treating patients with difficult-to-control hypertension.
Healthcare professionals can find more information about TRYVIO at www.TRYVIOhcp.com, while patients can visit www.TRYVIO.com. The current Full Prescribing Information, including a Boxed Warning, remains available through these resources.
