Gilead's Letairis gets FDA OK for WHO Class I/II pulmonary arterial hypertension

The US Food and Drug Aministration's approval of Letairis (ambrisentan) as a once-daily treatment for pulmonary arterial hypertension is, according to the drug's California-based manufacturer Gilead Sciences, a significant breakthrough for patients wishing to delay progression of the disease. Specifically, 5mg and 10mg formulations of the product have been cleared for the treatment of PAH sufferers diagnosed as having World Health Organization Functional Class II or III PAH symptoms.

Gilead said that the product will be made available through the Letairis Education and Access scheme, a restricted distribution program, due to the risk of liver injury and birth defects with which it is associated. GlaxoSmithKline, which holds rights to the product outside the USA (Marketletter October 9, 2006), submitted it for European Medicines Agency (EMEA) consideration earlier this year (Marketletter April 2).

AIRIES 1 and 2 demonstrate efficacy