Home Medizin FDA genehmigt neues Medikament gegen resistente Hypertonie

FDA genehmigt neues Medikament gegen resistente Hypertonie

von NFI Redaktion

The US Food and Drug Administration (FDA) has approved Aprocitentan (Tryvio) for lowering blood pressure in combination with other antihypertensive medications in adults with treatment-resistant hypertension.

Aprocitentan is the first endothelin receptor antagonist approved for patients with high blood pressure. The recommended dose is 12.5 mg orally once daily, with or without food.

The effectiveness and safety of Aprocitentan were demonstrated in the Phase 3 PRECISION study involving 730 adults with systolic blood pressure ≥ 140 mmHg who were prescribed at least three antihypertensive medications.

Aprocitentan (12.5 mg daily) was well-tolerated and statistically superior to placebo in reducing blood pressure after 4 weeks, with sustained effects observed after 40 weeks.

Subgroup analyses indicated that the antihypertensive effect of Aprocitentan appeared consistent across subgroups defined by age, gender, race, body mass index, estimated glomerular filtration rate at baseline, albumin-creatinine ratio at baseline in urine, and history of diabetes, as well as between blood pressure measurement methods.

“Transformative Progress”

“We had to wait over 30 years for the approval of an oral antihypertensive medication working on a new therapeutic pathway, making Tryvio a transformative progress in the field of systemic hypertension,” commented study researcher Michael A. Weber, MD, from the State University of New York, in a press release.

“It is taken as a single daily oral dose, working in conjunction with all other prescribed medications and without drug interactions in patients burdened with uncontrolled hypertension. Tryvio is easy for physicians to prescribe and for patients to use,” Weber added.

The company notes that Aprocitenan is expected to be available in the second half of this year. Due to the risk of embryo-fetal toxicity, it will only be available through a REMS program (Risk Evaluation and Mitigation Strategy).

Prescribing physicians must be certified for the Tryvio REMS program by enrolling and completing training. Pharmacies dispensing the medication must also be certified for the program.

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