The FDA has approved an orphan drug, ambrisentan (Letairis, Gilead), for patients with pulmonary arterial hypertension. This rare, life-threatening condition is characterized by continuous high blood pressure within the arteries of the lungs.
Ambrisentan was granted a priority review. The drug’s safety and effectiveness were demonstrated in two international clinical trials. Ambrisentan significantly improved physical activity capacity, compared with a placebo, in a six-minute walk, and it delayed the worsening of pulmonary hypertension.
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This drug should not be used by pregnant women or by women who might become pregnant. Monthly blood tests are required to check for potential liver injury.
Ambrisentan will be available as 5-mg and 10-mg once-daily tablets. Gilead holds the U.S. rights to this agent; Glaxo-SmithKline holds rights outside the U.S.