Actelion has announced the commercial availability of the oral, selective, IP prostacyclin receptor agonist, UPTRAVI® (selexipag) for the treatment of pulmonary arterial hypertension (PAH) in the US.
UPTRAVI is indicated for the treatment of pulmonary arterial hypertension (PAH, WHO Group I) to delay disease progression and reduce the risk of hospitalization for PAH.
Effectiveness was established in a long-term study in PAH patients with WHO Functional Class II-III symptoms. Patients had idiopathic and heritable PAH (58%), PAH associated with connective tissue disease (29%), PAH associated with congenital heart disease with repaired shunts (10%).
Richard Channick, MD, Director, Pulmonary Hypertension and Thromboendarterectomy Program, Massachusetts General Hospital, Boston commented: "After 20 years of prostacyclin therapy I am very excited to have UPTRAVI, an oral treatment that targets the prostacyclin pathway and is proven to improve long-term outcomes for patients. Furthermore, with UPTRAVI we can now use oral combination therapy regimens that target the three established treatment pathways for PAH, an option that could change the way we treat PAH in the long-term."
Bill Fairey, President of Actelion Pharmaceuticals US, commented: "Today's announcement represents a milestone for PAH treatment in the US - the availability of a new oral medication that effectively targets the prostacyclin pathway. We are proud to bring an oral treatment to patients which is supported by robust outcome-based evidence in combination with an ERA, or a PDE-5 inhibitor, and even in combination with both an ERA and a PDE-5 inhibitor. "
Rino Aldrighetti, President and CEO of the Pulmonary Hypertension Association spoke of the impact of the availability of UPTRAVI on the PAH community: "We at the Pulmonary Hypertension Association welcome new treatment options that help patients and their families affected by this devastating disease. We hope that UPTRAVI, will enable physicians to impact the long-term outcome for many of their PAH patients."
The safety of UPTRAVI has been evaluated in a long-term, placebo-controlled study enrolling 1,156 patients with symptomatic PAH (GRIPHON study). The exposure to UPTRAVI in this trial was up to 4.2 years with median duration of exposure of 1.4 years. Adverse reactions occurring more frequently on UPTRAVI compared to placebo - greater than or equal to 3% - over the course of the study, were headache, diarrhea, jaw pain, nausea, myalgia, vomiting, pain in extremity, flushing, arthralgia, anemia, decreased appetite and rash. These adverse reactions are more frequent during the dose titration phase. Hyperthyroidism was observed in 1% (n=8) of patients on UPTRAVI and in none of the patients on placebo.
UPTRAVI is available in the following strengths: 200 mcg [Light yellow tablet debossed with 2], 400 mcg [Red tablet debossed with 4], 600 mcg [Light violet tablet debossed with 6], 800 mcg [Green tablet debossed with 8], 1000 mcg [Orange tablet debossed with 10], 1200 mcg [Dark violet tablet debossed with 12], 1400 mcg [Dark yellow tablet debossed with 14], 1600 mcg [Brown tablet debossed with 16]. Full prescribing information can be found on www.uptravi.com.