The FDA ( Food and Drug Administration ) has approved Letairis ( Ambrisentan ) for the treatment of pulmonary arterial hypertension, a rare, life-threatening condition characterized by continuous high blood pressure within the arteries of the lungs.

In pulmonary arterial hypertension, the small arteries in the lungs become narrowed or blocked, and the heart must work harder to pump the blood through them. Over time, the overworked heart muscle may become weak and lose its ability to pump enough blood through the lungs.
Symptoms include shortness of breath, fatigue, chest pain, dizzy spells and fainting.
About 100,000 people in the United States have pulmonary arterial hypertension.

The safety and effectiveness of Letairis were demonstrated in two international clinical trials involving 393 patients. Letairis significantly improved physical activity capacity compared with a placebo, as shown by a six-minute walk, a standard test. Letairis also delayed the worsening of the pulmonary hypertension.

The most common side effects in patients using Letairis included swelling of legs and ankles, nasal congestion, sinusitis, and flushing.

Letairis should not be used by women who are pregnant or may become pregnant because the drug may cause birth defects. Patients taking Letairis must have monthly blood tests to check for potential liver injury.

Letairis will be available in five-milligram and 10-milligram once-daily tablets.

Letairis was granted orphan drug status by FDA because it treats a rare disease and meets other criteria. Orphan.

Source: FDA, 2007

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