EU's CHMP reviewing hepatotoxic profile of Actelion's Tracleer and GSK's Volibris
This article was originally published in Scrip
Executive Summary
Following the news that Pfizer is withdrawing its pulmonary arterial hypertension (PAH) drug Thelin (sitaxentan) from worldwide markets after three unpredictable, unpreventable cases of fatal liver injury (scripintelligence.com 13 December 2010), the EU's CHMP is starting a review of the hepatotoxic profile of the other endothelin receptor antagonists - Actelion's Tracleer (bosentan) and GlaxoSmithKline's Volibris (ambrisentan) - to confirm that they remain a valuable option in the treatment of PAH.