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FDA Approves Uptravi for Pulmonary Arterial Hypertension

The drug will be made available in the U.S. in early 2016

The FDA has approved selexipag (Uptravi, Actelion), a selective IP prostacyclin receptor agonist indicated for the treatment of pulmonary arterial hypertension (PAH, World Health Organization [WHO] Group I) to delay disease progression and reduce the risk of hospitalization for PAH.

The medication’s 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%), and PAH associated with congenital heart disease with repaired shunts (10%).

"The prostacyclin pathway has long been recognized as a key target in PAH treatment,” said Vallerie McLaughlin, MD, Director of the Pulmonary Hypertension Program in the Division of Cardiovascular Medicine at the University of Michigan. “However, until now, it has been underutilized. This is in part due to the significant burden existing prostanoid treatments have placed on the patients and on those supporting them. The approval of Uptravi with its convincing long-term outcome results means that many more patients can benefit from this pathway and be treated much earlier in the course of their disease."

The safety of Uptravi was evaluated in a long-term, placebo-controlled study enrolling 1,156 patients with symptomatic PAH (the GRIPHON study). The exposure to Uptravi was up to 4.2 years, with median duration of exposure of 1.4 years.

Adverse reactions occurring more frequently with 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.

Actelion expects Uptravi to become available to patients in the United States in early January 2016. Outside of the United States, Actelion continues to work with health authorities to obtain regulatory approval for Uptravi.

Source: Actelion, December 22, 2015.

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