hapapapa
The US Food and Drug Administration (FDA) has granted Johnson & Johnson (NYSE:JNJ) the approval of its oral combination therapy, Opsynvi, as a treatment for adults with pulmonary arterial hypertension (PAH), a fatal blood vessel disease.
Accordingly, Opsynvi, a single tablet comprising the The endothelin receptor antagonist macitentan and the phosphodiesterase 5 (PDE5) inhibitor tadalafil will be indicated in the United States for adults with certain types of PAH as a first- or last-line option.
The FDA approval is based on the company’s Phase 3 A DUE study, in which Opsynvi outperformed tadalafil or macitentan monotherapy over 16 weeks in addressing pulmonary vascular resistance.
The treatment comes with a Boxed Warning to indicate the risk of toxicity to the fetus during pregnancy. Female patients taking Opsynvi are required to enroll in a federal program called the Risk Evaluation and Mitigation Strategy (REMS) designed to monitor drug safety issues.