FDA Greenlights Idorsia’s Aprocitentan (Tryvio) for Resistant Hypertension Patients

1. The FDA approved Idorsia's novel drug, aprocitentan (brand name Tryvio), for treating patients with resistant hypertension on March 20, 2024.
2. Tryvio is an endothelin receptor antagonist, representing a new therapeutic approach to managing hypertension.
3. The drug is intended to be used in combination with existing antihypertensive medications for patients who remain uncontrolled on other treatments.
4. The recommended starting dosage of Tryvio is 12.5 mg administered orally once daily.
5. The approval is supported by data from the PRECISION trial, which involved 730 patients with high blood pressure and evaluated the safety and efficacy of aprocitentan.
6. The PRECISION trial demonstrated that aprocitentan 12.5 mg significantly reduced sitting systolic blood pressure compared to placebo.
7. Common adverse events associated with Tryvio include edema and fluid retention.
8. Tryvio is expected to become commercially available during the second half of 2024.
9. The drug will be distributed through a Risk Evaluation and Mitigation Strategy (REMS) program requiring one-time registrations for both physicians and pharmacists.