Johnson & Johnson’s Yuvanci (macitentan and tadalafil) Receives the CHMP’s Positive Opinion for Treating Pulmonary Arterial Hypertension (PAH)
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The CHMP has granted positive opinion to Yuvanci [macitentan (10mg) + tadalafil (40mg)] as a substitution therapy of PAH adults, based on P-III (A DUE) study
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The P-III (A DUE) trial assessed Yuvanci STCT vs macitentan (10mg) & tadalafil (40mg) alone in PAH patients (n=187). Subjects with PVR ≥240 dyn×s/cm5 randomly received M/T STCT (n=108), macitentan alone (n=35) or tadalafil alone (n=44), QD
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Trial reached its 1EP, showing reduced PVR (as a ratio of wk.16 to baseline) of 29% (effect of 0.71) vs macitentan & 28% (effect of 0.72) vs tadalafil, with similar efficacy observed in subgroups of age, sex, race & baseline WHO FC as well as among treatment-naïve or experienced patients (with ERA or PDE5i)
Ref: Johnson & Johnson | Image: Johnson & Johnson
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A passionate content writer with expertise in delivering high-quality and engaging content, Dipanshu is a keen reader and a versatile writer. Dipanshu dedicatedly covers news ranging from biopharma, life sciences, biotech, and MedTech to diagnostics and animal health companies. He can be contacted at connect@pharmashots.com
