Johnson & Johnson has announced the approval of OPSYNVI® by the U.S. Food and Drug Administration (FDA), marking a significant advancement in the treatment of pulmonary arterial hypertension (PAH). OPSYNVI® is the first and only once-daily single-tablet combination therapy for adults with PAH, offering a simplified treatment regimen.

PAH, a rare and life-threatening blood vessel disorder, necessitates comprehensive treatment to manage symptoms and improve patient outcomes. OPSYNVI® combines macitentan, an endothelin receptor antagonist, and tadalafil, a phosphodiesterase 5 inhibitor, into a single tablet, offering convenience and effectiveness in disease management.

Dr. Kelly Chin, Professor of Internal Medicine and Director of the Pulmonary Hypertension Program at UT Southwestern Medical Center, underscores the significance of OPSYNVI®: "As administration of macitentan and tadalafil together are commonly prescribed for initial therapy for PAH, the introduction of a single tablet combining both is promising for clinicians treating patients as it may help bridge the gap between clinical guidelines and everyday clinical practice, while offering a patient-friendly approach to support initial combination therapy and rapid escalation for the appropriate patients."

The FDA approval is based on the results of the pivotal Phase 3 A DUE study, demonstrating significant pulmonary hemodynamic improvement with OPSYNVI® compared to monotherapy. OPSYNVI® offers greater reduction in Pulmonary Vascular Resistance (PVR) after 16 weeks versus tadalafil or macitentan monotherapy.

While OPSYNVI® presents a breakthrough in PAH treatment, it carries a Boxed Warning due to the risk of embryo-fetal toxicity, requiring female patients to enroll in the Macitentan-Containing Products Risk Evaluation and Mitigation Strategy (REMS) program.

Dr. James F. List, Global Therapeutic Area Head overseeing Pulmonary Hypertension programs at Johnson & Johnson, emphasizes the potential impact of OPSYNVI® in optimizing disease management: "We're thrilled to bring this single-tablet combination therapy to patients, as it has the potential to optimize disease management and fulfill a significant unmet need in supporting recently updated treatment guidelines that call for initial or early combination treatment."

With the approval of OPSYNVI®, Johnson & Johnson expands its PAH portfolio, addressing all three foundational and guideline-recommended pathways – nitric oxide, endothelin, and prostacyclin, reaffirming its commitment to advancing treatments for rare diseases.