U.S. FDA approves orphan drug Letairis for pulmonary hypertension

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Ghislaine SURREL

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On Friday, June 15, 2007, the U.S. Food and Drug Administration (FDA) gave marketing approval to Letairis (ambrisentan) for the treatment of pulmonary arterial hypertension, a dangerous condition in which blood pressure increases in the arteries in the lungs. According to the FDA, about 100,000 people in the United States have pulmonary arterial hypertension. Letairis was shown to be safe and effective in two international clinical trials. It is not approved for use during pregnancy. Side effects may include swelling (edema) of legs and ankles, nasal congestion, sinusitis, and getting red in the face (flushing).

• Prescribing information for Letairis
• FDA press release about Letairis approval

Tuesday June 19, 2007 |

http://rarediseases.about.com/b/a/257672.htm

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