The FDA has approved Tyvaso (treprostinil inhalation solution, from United Therapeutics), a prostacyclin vasodilator, for the treatment of pulmonary arterial hypertension (PAH) using the Tyvaso Inhalation System. Tyvaso is indicated to increase walk distance in patients with NYHA Class III symptoms associated with World Health Organization (WHO) Group I PAH, which includes multiple etiologies such as idiopathic and familial PAH as well as PAH associated with scleroderma and congenital heart disease. This approval is based on results from the TRIUMPH-1 study, a randomized, double-blind, 12-week, placebo-controlled clinical trial that showed patients treated with Tyvaso to have achieved a 20-meter improvement in six-minute walk distance over those taking placebo (p<0.0005).
Tyvaso is expected to be available in September 2009.
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