GILEAD SUBMITS APPLICATION FOR HYPERTENSION DRUG

Gilead Sciences has submitted a new drug application to the FDA for ambrisentan (5 mg and 10 mg) for the once-daily treatment of pulmonary arterial hypertension (PAH). The application is supported by data from two Phase III clinical studies (ARIES-1 and ARIES-2) and three Phase II studies in patients with PAH.

In the two ARIES clinical trials, patients were randomized in a blinded fashion to receive placebo or one of two doses of ambrisentan. The trials were of identical design except for the doses of ambrisentan studied and the locations of the investigative sites. Both trials were designed to enroll 186 patients (62 patients per dose group). ARIES-1 evaluated once-daily doses of 5 mg and 10 mg of ambrisentan. ARIES-2 evaluated once-daily doses of 2.5 mg and 5 mg of ambrisentan. ARIES-1 enrolled 202 patients primarily in the United States while ARIES-2 enrolled 192 patients primarily in Europe. Approximately 400 patients from these and other studies are continuing ambrisentan treatment in long-term clinical trials.

Ambrisentan is a non-sulfonamide, propanoic acid-class, endothelin receptor antagonist that is selective for the endothelin type-A 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 U.S. and European Union.

Gilead acquired the U.S. rights to ambrisentan when it completed its acquisition of Myogen in November. GlaxoSmithKline holds rights to commercialize ambrisentan outside the U.S.