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The U.S. Food and Drug Administration (FDA) has granted Johnson & Johnson (NYSE:JNJ) approval for its oral therapy combination, Opsynvi, as a treatment for adults with pulmonary arterial hypertension (PAH), a fatal blood vessel disorder.
Accordingly, Opsynvi, a single tablet comprising the endothelin receptor antagonist macitentan and the phosphodiesterase 5 (PDE5) inhibitor tadalafil, will be indicated in the U.S. for adults with certain types of PAH as a first-line or late-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 unborn during pregnancy. Female patients on Opsynvi are required to enroll in a federal program called the Risk Evaluation and Mitigation Strategy (REMS) designed to monitor drug safety issues.
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