The application is supported by data from two phase III clinical studies and three phase II studies in patients with pulmonary arterial hypertension (PAH) and Gilead is asking for approval of both 5-milligram and 10-milligram doses of ambrisentan. Ambrisentan is an investigational compound and has not yet been determined safe or efficacious in humans.
“Current therapeutic options are limited, and there remains an urgent need for safe and effective treatments for patients with PAH,” said John Martin, president and CEO, Gilead Sciences.
Ambrisentan is selective for the endothelin type-A (ETa) receptor. Endothelin is a small peptide hormone that plays a critical role in the control of blood flow and cell growth. Elevated endothelin blood levels are associated with PAH. Ambrisentan has been granted orphan drug designation for the treatment of PAH in both the US and European Union.
Gilead acquired the US rights to ambrisentan when it completed its acquisition of Myogen in November. GlaxoSmithKline holds rights to commercialize ambrisentan outside of the US.