FDA permits Gilead to drop liver injury warning for Letairis
This article was originally published in Scrip
Executive Summary
The US FDA has permitted Gilead Sciences to remove language about a potential risk of liver injury from the black-box warning in the labelling of its pulmonary arterial hypertension (PAH) drug Letairis (ambrisentan). The agency also is no longer requiring PAH patients receiving Letairis to obtain monthly liver function tests – giving the drug significant advantages over Actelion's PAH drug Tracleer (bosentan).