FDA Approves Combination Therapy for PAH


J&J’s Opsynvi is single-tablet combination of macitentan, an endothelin receptor antagonist, and tadalafil, a PDE5 inhibitor. It will be priced on parity with Opsumit, which is also a J&J product to treat patients with pulmonary arterial hypertension.

The FDA has approved Opsynvi to treat adult patients with pulmonary arterial hypertension (PAH). Pulmonary arterial hypertension is a rare, progressive and disorder characterized by the constriction of small pulmonary arteries and elevated blood pressure in the pulmonary circulation. This blocks blood flow to the lungs. An estimated 500 to 1,000 new cases of PAH are diagnosed each year in the United States, according to the American Lung Association.

Developed by Johnson & Johnson, Opsynvi is a single-tablet combination of macitentan, an endothelin receptor antagonist (ERA), and tadalafil, a phosphodiesterase 5 (PDE5) inhibitor. Macitentan is sold by J&J under the name of Opsumit. Tadalafil is sold by both as a generic and under the brand names of Cialis for erectile dysfunctin and Adcirca for PAH by Lilly. In PAH, tadalafils help to relax blood vessels, making it easier for the heart to pump.

Kelly Chin, M.D.

Kelly Chin, M.D.

Macitentan and tadalafil together are commonly prescribed for initial therapy for PAH, Kelly Chin, M.D., professor of Internal Medicine and director of the Pulmonary Hypertension Program at UT Southwestern Medical Center, and an investigator, said in a press release. “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,” she said.

The list price of Opsynvi will be at parity to Opsumit, according to a spokesperson for J&J, and patients won’t have to pay any out-of-pocket costs related to separate PDE5 inhibitor prescription. The cost for Opsumit oral tablet 10 mg is around $6,662 for a supply of 15 tablets, according to Drugs.com.

J&J had submitted the new drug application for the macitentan and tadalafil combination in May 2023. The approval of Opsynvi is based on the results from the pivotal phase 3 A DUE study, which showed the combination was superior to either macitentan and tadalafil used as a monotherapy in patients with PAH. In the study, Opsynvi demonstrated greater reduction in pulmonary vascular resistance (PVR) after 16 weeks versus tadalafil or macitentan monotherapy.

The A DUE study was designed to compare the efficacy and safety of Opsynvi to macitentan and tadalafil monotherapies in adult patients with PAH. The three-arm trial enrolled patients who were treatment-naïve or on a stable dose of an endothelin receptor antagonist (ERA), or a phosphodiesterase 5 (PDE5) inhibitor, for at least three months. Following the treatment period, patients transitioned to the open-label treatment period for 24 months. The open-label arm is ongoing.

Anemia and hypotension were common adverse events of the combination therapy. Results from A DUE were presented at the American College of Cardiology’s 72nd Annual Scientific Session & Expo in March 2023.

Opsynvi has a boxed warning because of the risk of embryo-fetal toxicity and requires women to enroll in the Macitentan-Containing Products Risk Evaluation and Mitigation Strategy (REMS) program.

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