Gilead submits US NDA for ambrisentan
US drugmaker Gilead Sciences has submitted a New Drug Application to the Food and Drug Administration for marketing approval of ambrisentan (5mg and 10mg) for the once-daily treatment of pulmonary arterial hypertension. This filing supported by data from two Phase III clinical studies (ARIES-1 and ARIES-2) and three Phase II studies in patients with PAH. Gilead noted that its non-sulfonamide endothelin type-A receptor antagonist is still being tested in 400 patients who are continuing treatment in long-term clinical trials.
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