The U.S. FDA approves OPSYNVI for a once-daily single-tablet combination therapy for patients with pulmonary arterial hypertension

Johnson & Johnson has recently announced that the U.S. FDA has approved OPSYNVI, for the chronic treatment of adults with pulmonary arterial hypertension and WHO functional class (FC) II-III. OPSYNVI^® may be used in patients with PAH who are treatment-naïve or who are already on an ERA, PDE5 inhibitor or both. OPSYNVI^® may be used in patients who are currently treated concomitantly with stable doses of macitentan 10 mg and tadalafil 40 mg as separate tablets.

PAH is a rare and life-threatening blood vessel disorder characterized by the constriction of small pulmonary arteries and elevated blood pressure in the pulmonary circulation that eventually leads to right heart failure.

“Clinical guidelines recommend treating patients with initial and sequential dual-combination therapy, regardless of risk at initial diagnosis and follow-up. Historically, this required patients to take multiple pills because no single-tablet combination therapy targeting two or more pathways was available,” said Kelly Chin, M.D., Professor of Internal Medicine and Director of the Pulmonary Hypertension Program at UT Southwestern Medical Center, and an investigator in the A DUE study.* “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’s approval of OPSYNVI is based on the results from the pivotal Phase 3 A DUE study, in which OPSYNVI demonstrated greater reduction in Pulmonary Vascular Resistance  after 16 weeks versus tadalafil or macitentan monotherapy. OPSYNVI has a Boxed Warning due to the risk of embryo-fetal toxicity and requires female patients to enroll in the Macitentan-Containing Products Risk Evaluation and Mitigation Strategy program.

“People with PAH often live with the burden of taking many pills each day, which can pose challenges,” said James F. List, M.D., Ph.D., Global Therapeutic Area Head, whose team oversees a portfolio of programs including Pulmonary Hypertension at Johnson & Johnson. “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.”

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Related Topics and Keywords

OPSYNVI® (macitentan and tadalafil), pulmonary arterial hypertension