FDA Approves the First New Type of High Blood Pressure Drug In Decades

FDA Approves the First New Type of High Blood Pressure Drug In Decades
  • The FDA approved a new treatment for uncontrolled high blood pressure.
  • The once-daily oral medication, called Tryvio (aprocitentan), is expected to be available in the second half of 2024.
  • Tryvio is approved for use in combination other antihypertensive medications.

The Food and Drug Administration (FDA) recently approved a new treatment for uncontrolled high blood pressure. 

Uncontrolled high blood pressure, or resistant hypertension, is hard to manage. Many people with resistant hypertension make lifestyle changes and take three or more medications, including a diuretic, but their blood pressure stays elevated.

About 20% of people with high blood pressure have resistant hypertension, which increases the risk of stroke, heart attack, and kidney failure.

Tryvio (aprocitentan), made by pharmaceutical company Idorsia, is a once-daily oral medication that helps lower blood pressure in adults with uncontrolled high blood pressure. It works by blocking the hormone endothelin from binding to receptors in blood vessels, preventing those blood vessels from constricting.3

Tryvio is the first endothelin receptor antagonist for resistant hypertension, though an endothelin receptor drug called Tracleer (bosentan) is approved to treat certain types of pulmonary arterial hypertension (high blood pressure in the lungs).

A new way to treat hypertension has been a long time coming. The last introduction of a new class of antihypertensive drugs, called renin inhibitors, was in 2007 with the approval of Tekturna (aliskiren). Not only are endothelin receptors a new class of drugs for hypertension; they also utilize the first new therapeutic pathway for lowering blood pressure in 40 years.

“Blocking receptors to endothelin produces vasodilatation. That means that the diameter of the small arteries of our body dilates and therefore, the blood pressure decreases,” Oscar Cingolani, MD, director of the hypertension program at Johns Hopkins Medicine, told Verywell.

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Researchers evaluated Tryvio in the PRECISION trial, which was conducted from 2018 to 2022. The drug was well-tolerated and lowered blood pressure in a small but significant number of participants when used with other medications.

“This is a medication that is relatively new, so we need to be aware of any potential side effects that could have been missed in the trial,” Cingolani said.

Is Tryvio Safe?

Some people might experience liver problems, fluid retention, decreased sperm count, or anemia while taking Tryvio.5

Pregnant people and anyone trying to get pregnant should not take Tryvio because the medication can cause miscarriage and birth defects. People who are breastfeeding should also avoid Tryvio because it is not known if the drug passes from the breast milk to the infant.

“The reason why I’m cautious is we don’t have long-term data from this medication,” Cingolani said. “We don’t have five years or a decade. We do have long-term experience from other similar medications, and they seem to be safe,” Cingolani said.

He said he plans to consider the medication as an option for patients with resistant hypertension once it is available in the second half of 2024.

“The FDA took a good two years to approve it. It went through all the studies, and I think the evaluation was quite rigorous,” he said. “I’m pretty confident that this is going to be a good medication.”

Tryvio Works With Other Drugs

People with high blood pressure often take a combination of medication from different classes like diuretics, angiotensin-converting enzyme inhibitors (ACE inhibitors), angiotensin II receptor blockers (ARBs), and calcium channel blockers.

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Tryvio is a joint endothelin A/endothelin B receptor antagonist that works via a different therapeutic pathway than other high blood pressure medications. This drug is only approved for use with other antihypertensive medications.

“It is not a panacea at all, and that’s what we expect. If you can get a bunch of different drugs with different mechanisms of action, they’ll work synergistically so you can get away with lower doses,” Karol E. Watson, MD, PhD, an attending cardiologist and a professor of medicine and cardiology at the David Geffen School of Medicine at UCLA, told Verywell.

Watson said that taking lower doses can help reduce side effects.

“Most people with hard-to-treat hypertension take four different classes of medication. And that’s not a failure of any one class; that’s just part of the complexity of the disease process,” she said.

Watson, like Cingolani, said she will keep Tryvio in her toolbox to treat resistant hypertension. However, it’s not the first medication she will reach for.

“It’s not a game changer, but it’s nice to have options,” Watson said.

Takeaway Note

Tryvio (aprocitentan) is a new drug for treating resistant hypertension. The medication could help people manage uncontrolled high blood pressure when used with other treatments. Experts doubt it will immediately become a first line of defense.


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