Johnson & Johnson's Opsynvi, a single-tablet combination of two existing compounds, has received approval from U.S. regulators to treat pulmonary arterial hypertension.
The pharmaceutical company said late on Friday that Opsynvi combined macitentan and tadalafil, had been approved for use in patients with PAH, a blood-vessel disorder, who are treatment-naive or who are already on similar types of treatments.
On their own, macitentan reduces the risk of hospitalization for PAH patients and tadalafil increases the ability to exercise, the company said.
Johnson & Johnson said the approval was based on its Phase 3 study, which found a greater reduction in pulmonary vascular resistance, a proxy for worse outcomes of the disease, among patients treated with the combination therapy than each treatment on its own.
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