Johnson & Johnson’s Yuvanci (macitentan and tadalafil) Receives the CHMP’s Positive Opinion for Treating Pulmonary Arterial Hypertension (PAH)
Shots:
-
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
-
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
-
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
Related News:- Johnson & Johnson Reports sNDA Submission of Spravato to the US FDA for Treatment-Resistant Depression
PharmaShots! Your go-to media platform for customized news ranging for multiple indications. For more information connect with us at connect@pharmashots.com
Tags
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, FDA, EMA, and biosimilar approvals. He can be contacted at connect@pharmashots.com
