FDA approves aprocitentan for treatment of hypertension in adults with uncontrolled BP
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Key takeaways:
- Aprocitentan has been approved to treat hypertension in patients whose BP is uncontrolled.
- The drug is the first oral antihypertensive therapy working via a new pathway to be approved in nearly 40 years.
Idorsia announced that the FDA has approved aprocitentan, its antihypertensive drug, for treatment of hypertension in combination with other drugs in patients whose BP is not adequately controlled on other drugs.
As Healio previously reported, in the PRECISION trial, aprocitentan (Tryvio, Idorsia), a joint endothelin A/endothelin B receptor antagonist, was superior to placebo for BP lowering in patients with resistant hypertension and was well tolerated.
The drug is the first oral therapy that works via a new therapeutic pathway to be approved for BP lowering in nearly 40 years, according to a press release from the company.
“Tryvio is the first medication for treating hypertension that works by blocking endothelin … which is a vasoconstrictor that raises blood pressure, and so is a very logical target for a new antihypertensive agent,” Healio | Cardiology Today Editorial Board Member Michael A. Weber, MD, professor of medicine in the division of cardiovascular medicine at the State University of New York, and an investigator in the PRECISION study, told Healio. “This treatment also results in reductions in two other important blood pressure-raising activities. No. 1, there’s a reduction in sympathetic activity. No. 2, there’s a reduction in aldosterone release. In a sense, this is a triple action: We are vasodilating, we are blocking some degree of sympathetic activity and we are blocking a certain amount of aldosterone activity, all of which would contribute to a reduction in blood pressure.”
The drug will be made commercially available in the second half of 2024, according to the release.
Weber told Healio that the most appropriate candidates for the drug are those whose blood pressure is not being adequately controlled by other medications and lifestyle modifications. “I can see this drug being used in patients where we have tried two, three or four other possibilities, and it would be given with perhaps three other medications at most, because that gives it and the other medications a chance of being taken by the patients,” he said.
He said that because of the multiple mechanisms of action, the drug may be suitable for “people who have hypertension and other problems at the same time, for instance, patients with chronic kidney disease. It seems to be effective in maintaining kidney function and reduces albuminuria or proteinuria, which is a useful and valuable contribution. I would imagine anyone who has hypertension and a previous cardiovascular or stroke event would be a strong candidate, because those patients are particularly vulnerable to poorly controlled hypertension. People with diabetes [are also] likely to benefit from this, because they are susceptible to kidney disease and also strokes and cardiovascular outcomes. I believe heart failure is very common in hypertensive patients, and is often hidden in hypertensive patients because we are giving the patients various drugs that apart from lowering blood pressure may also be somewhat beneficial for treating heart failure. [Aprocitentan] could be very helpful for people with heart failure, especially people with preserved ejection fraction, [though] I would be sure they were getting an adequate diuretic therapy as well, because vasodilators do allow some fluid retention.”
In PRECISION, aprocitentan significantly lowered BP compared with placebo by week 4 and results were sustained out to 40 weeks. The most common adverse events from aprocitentan were edema/fluid retention and anemia.
Aprocitentan is contraindicated in patients who are hypersensitive to aprocitentan or any of its excipients, and in patients who are pregnant, according to the release.
“We will know a lot more when we start using it in clinical practice and see the types of patients who appear to get benefits,” Weber told Healio.
For more information:
Michael A. Weber, MD, can be reached at michaelwebermd@cs.com.
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