New Orphan Drug For Pulmonary Hypertension

On Friday June 15th 2007, the Food and Drug Administration (FDA) approved a new drug for the treatment of pulmonary arterial hypertension. Letairis (ambrisentan) is an endothelin receptor antagonist which belongs to a broader class of drugs known as vasodilators.

In clinical studies, Letairis (ambrisentan) was found to improve the capacity for physical activity in affected individuals and also to delay the worsening of pulmonary hypertension. Common side effects include facial flushing (getting red in the face), swollen legs and ankles, sinusitis, and nasal congestion.

Letairis (ambrisentan) comes with a black box warning about potential liver injury and contraindication in pregnancy - the drug is very likely to produce serious birth defects if used by pregnant women. Monthly blood tests to assess liver function are required for all patients who will be using this drug.

Because Letairis (ambrisentan) is used to treat a rare disease (and due to certain other criteria it meets), FDA has granted it orphan drug designation. Manufactured by Gilead Sciences, Inc. in Foster City California, the drug will be available in 5mg and 10mg tablets which will be taken once daily.

Photo courtesy of permanently scatterbrained