dm+d
Unassigned
New Medicines
Pulmonary arterial hypertension (PAH) - fixed-dose combination preparation for adults adequately controlled with macitentan 10mg and tadalafil 40mg administered as separate tablets
Information
New formulation
Actelion
Actelion
Development and Regulatory status
None
Phase III Clinical Trials
None
Feb 21PIII A DUE study (NCT03904693) is ongoing with an estimated primary completion date of Dec 23 [4].
Category
Fixed-dose combination of macitentan (an endothelin receptor antagonist) and tadalafil (a phosphodiesterase type-5 inhibitor)
Idiopathic PAH is rare. However, the prevalence of PAH is higher in certain patient groups, such as those with systemic sclerosis, portal hypertension, congenital heart disease and HIV infection. The prevalence of PAH is estimated at 15-52 per million. The incidences are estimated to be 1-3.3 per million per year for idiopathic PAH and 1.75-3.7 per million per year for chronic thromboembolic PH [1].
Pulmonary arterial hypertension (PAH) - fixed-dose combination preparation for adults adequately controlled with macitentan 10mg and tadalafil 40mg administered as separate tablets
Oral