There is exciting news for people living with pulmonary arterial hypertension (PAH). A new medication called ralinepag has shown strong results in a large clinical trial.
PAH is a serious disease that causes high blood pressure in the blood vessels of the lungs. Over time, this makes the heart work harder and can lead to heart failure.
What Is Ralinepag?
Ralinepag is a new pill taken once a day. It works by helping the blood vessels in the lungs relax and open wider. This makes it easier for blood to flow through the lungs.
What kinds of patients were included in the study?
- Most patients were on two oral treatments
- Most patients were doing fairly well at baseline
- No patients on Winrevair (sotatercept) were included in the study
- No patients on prostaoind therapy (Remodulin, Tyvaso, Uptravi, Flolan or Yutrepia) were included
What Did the Study Find?
The study, called ADVANCE OUTCOMES, included 687 people with PAH. Most were already taking other PAH medications.
The results were very encouraging:
- 55% lower risk of PAH getting worse: Patients taking ralinepag were much less likely to have their disease worsen than those taking a placebo (a pill with no active drug).
- Better walking distance: After 28 weeks, patients taking ralinepag could walk about 67 feet farther in six minutes compared with those taking a placebo.
- Better heart health: Blood tests showed signs of less strain on the heart.
Importantly, the benefits were seen in patients who were already taking other PAH treatments.
What About Side Effects?
The most common side effects were headache, diarrhea, nausea, and muscle pain. About 19% of patients taking ralinepag stopped treatment because of side effects, compared with 3% taking placebo.
The study did not show a clear reduction in deaths or hospital stays.
When Will Ralinepag Be Available?
Ralinepag is not yet approved by the FDA. The FDA is now reviewing the drug and is expected to make a decision by June 24, 2027.
The Bottom Line
When approved, Ralinepag will be an important new treatment option for people with PAH. The results suggest that adding this once-daily pill to existing treatments can help slow the disease and improve exercise capacity.
As more treatments are approved, building the best treatment regimen becomes increasingly complicated. It is vital to work closely with your PAH specialist.
