New PAH Drug, Uptravi, Closer to Approval in Europe
Action Pharmaceuticals recently announced the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has released a positive opinion on the use of Uptravi (selexipag) for the treatment of patients with a diagnosis of pulmonary arterial hypertension (PAH).
Uptravi is an oral IP prostacyclin receptor agonist. The drug acts by relaxing muscles in the walls of blood vessels to dilate (open) them, decreasing the elevated pressure in the vessels supplying blood to the lungs.
The drug received CHMP’s approval for patients with a diagnosis of PAH with the WHO functional class II-III, either as a combined treatment in those whose disease is insufficiently controlled through the use of an endothelin receptor antagonist (ERA) and/or a phosphodiesterase type 5 (PDE-5) inhibitor, or as stand-alone solution for patients not eligible for these treatments. The committee’s positive opinion will now be considered by the European Commission, which issues final approval.