pulmonary arterial hypertension Archives

How the FDA approval of J&J’s Opsynvi could simplify treatment and improve outcomes for PAH patients

[J&J]

Pulmonary arterial hypertension (PAH), a rare, progressive and life-threatening blood vessel disorder, affects some 500 to 1,000 new patients each year in the U.S. FDA recently approved Opsynvi, a first-of-its-kind once-daily single-tablet combination therapy from Johnson & Johnson.

“With this approval, our portfolio now includes treatments that address all three guideline-recommended pathways,” said a J&J spokesperson, highlighting the therapy’s alignment with current clinical guidelines recommending early use of combination therapy. The three treatment pathways include the endothelin, prostacyclin and nitric oxide (NO)-soluble guanylate cyclase (sGC)-cyclic guanosine monophosphate (cGMP) pathways.

The impact of Opsynvi PAH combination therapy

Before the approval, the DUE study for the combination therapy was featured in The Journal of the American College of Cardiology. The tria…

How the FDA approval of J&J’s Opsynvi could simplify treatment and improve outcomes for PAH patients

[J&J]

Pulmonary arterial hypertension (PAH), a rare, progressive and life-threatening blood vessel disorder, affects some 500 to 1,000 new patients each year in the U.S. FDA recently approved Opsynvi, a first-of-its-kind once-daily single-tablet combination therapy from Johnson & Johnson.

“With this approval, our portfolio now includes treatments that address all three guideline-recommended pathways,” said a J&J spokesperson, highlighting the therapy’s alignment with current clinical guidelines recommending early use of combination therapy. The three treatment pathways include the endothelin, prostacyclin and nitric oxide (NO)-soluble guanylate cyclase (sGC)-cyclic guanosine monophosphate (cGMP) pathways.

The impact of Opsynvi PAH combination therapy

Before the approval, the DUE study for the combination therapy was featured in The Journal of the American College of Cardiology. The tria…

Fixed-dose macitentan-tadalafil polypill outperforms monotherapies in PAH

A visualization of the cardio-pulmonary system [Adobe Stock]

Pulmonary arterial hypertension (PAH) is a relatively rare disorder, affecting roughly 15 to 50 people per million within the U.S. and Europe. Treating it with a single therapy can be challenging, and medication adherence often presents a common hurdle for the condition. Combination therapy has thus become a widely used option in the treatment of the condition, as the American Journal of Cardiovascular Drugs noted in 2018. The 2022 guidelines from the European Respiratory Society and European Society for Cardiology (ERS/ESC) further support the combination approach, emphasizing the importance of initial combination therapy in personalized PAH treatment strategies.

The promise of a macitentan-tadalafil polypill

Highlighted in The Journal of the American College of Cardiology, the DUE study focused on a once-daily, single-tablet combination of macitentan…