Tryvio Approved for Hypertension
On March 19, 2024, the U.S. Food and Drug Administration (FDA) approved Idorsia Pharmaceutical’s Tryvio™ (aprocitentan) for the treatment of hypertension in combination with other antihypertensive drugs, to lower blood pressure in adult patients who are not adequately controlled on other drugs. Tryvio works by blocking endothelin receptors and relaxing blood vessels to lower blood pressure. The recommended dose is 12.5mg orally once per day. Tryvio comes with a boxed warning that it may cause embryo-fetal toxicity. Idorsia intends to launch Tryvio sometime in the second half of 2024. Cost is not available at this time. For full prescribing information, see here.
At a Glance
- Brand (Generic) Name: Tryvio (aprocitentan)
- Manufacturer: Idorsia Pharmaceuticals
- Date Approved: March 19, 2024
- Indication: to treat hypertension in combination with other antihypertensive drugs, to lower blood pressure in adult patients who are not adequately controlled on other drugs.
- Dosage Forms Available: 12.5mg tablets
- Launch Date: sometime in the second half of 2024
- Estimated Cost: Not available at this time
- An endothelin antagonist, Tryvio works by inhibiting the binding endothelin (ET)-1 to ETA and ETB receptors, resulting in the relaxation of blood vessels to reduce blood pressure.
- Hypertension affects around 116 million adults in the U.S., or nearly half the population, and is a significant health concern. About 10% of these individuals experience resistant hypertension, where blood pressure remains high despite treatment. Resistant hypertension is a type of high blood pressure that is difficult to control with standard treatments.
- There are multiple agents available for the treatment of hypertension, and the majority of them are available generically. However, patients with treatment-resistant hypertension could use additional treatment options for managing their disease.
- Tryvio comes with a boxed warning noting that it is contraindicated in pregnancy and patients should not become pregnant for up to one month after stopping Tryvio. Patients who can become pregnant should use contraception before starting treatment.
- Due to Tryvio’s potential for causing birth defects, it is only available through a risk evaluation and mitigation strategy (REMS) in which prescribers and pharmacies must be certified.
- In its pivotal trial, PRECISION, Tryvio was evaluated in patients with resistant hypertension. At week 4, patients who received Tryvio had significantly lower sitting systolic blood pressure (SiSBP) than those who received placebo. These effects were sustained through week 40 of the study.
- The most frequent adverse events (AEs) were swelling/fluid retention and anemia.