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

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 trial investigated a once-daily, single-tablet combination of macitentan (10 mg) and tadalafil (40 mg) for PAH in 187 patients with WHO functional class II-III PAH. The patients were split into three groups: 108 received the combination therapy. An additional 35 and 44 participants received macitentan and tadalafil monotherapies, respectively.

The phase 3 DUE study found that the combination therapy was associated with a greater reduction in Pulmonary Vascular Resistance (PVR) after 16 weeks compared with tadalafil or macitentan alone. The trial outcome supports the use of Opsynvi as an initial therapy option in PAH, especially in patients classified in the WHO functional class II-III.

Opsynvi’s role in personalized PAH management

The therapy offers flexibility in treatment regimens. It can be prescribed to both newly diagnosed patients and those already receiving other PAH medications, such as endothelin receptor antagonists (ERAs) or phosphodiesterase-5 (PDE5) inhibitors. This allows doctors to tailor treatment to individual patient needs, considering factors like disease progression, other health conditions, and existing medications. Additionally, as PAH progresses, treatment adjustments may be necessary. OPSYNVI’s versatility can be beneficial in managing these changes throughout a patient’s journey with the disease.

A J&J spokesperson emphasized the company’s commitment to ensuring patient access to Opsynvi, stating, “When covered, patients will pay no more for OPSYNVI than they would for macitentan (OPSUMIT), foregoing any OOP cost of a separate PDE5 inhibitor prescription.” J&J also offers patient assistance programs to ease medication affordability. 

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Filed Under: Cardiovascular, Rare disease, Regulatory affairs
Tagged With: combination therapy, DUE study, FDA approval, J&J, macitentan, pulmonary arterial hypertension, tadalafil
 

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