ERS 2014: AMBITION study of ambrisentan/tadalafil combo meets primary endpoint in PAH

US biotech major Gilead Sciences (Nasdaq: GILD) today released results from the AMBITION study (a randomized, double-blind, multicenter study of first-line combination therapy with AMBrIsentan and Tadalafil in patients with pulmonary arterial hypertensION), which was conducted in collaboration with GlaxoSmithKline (LSE: GSK).

In AMBITION, first-line treatment of pulmonary arterial hypertension (PAH) with the combination of ambrisentan 10mg and tadalafil 40mg reduced the risk of clinical failure by 50 percent compared to the pooled ambrisentan and tadalafil monotherapy arm (hazard ratio = 0.502; 95% CI: 0.348, 0.724; p=0.0002). The combination was also statistically significant versus the individual ambrisentan and tadalafil monotherapy groups for the primary endpoint (p<0.01). Rates of serious adverse events and events leading to discontinuation were similar across treatment arms. Detailed results from the study will be presented today during an oral session at ERS International Congress 2014, the annual meeting of the European Respiratory Society.

sNDA filing planned by year-end