The FDA has cleared Tyvaso (treprostinil) Inhalation Solution for the treatment of pulmonary arterial hypertension (PAH).
Developed by United Therapeutics Corp., of Silver Spring, Md., treprostinil is indicated to increase walk distance in patients with New York Heart Association Class III symptoms associated with 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.
“We are thrilled to have a fourth approval from the FDA for treatment of this serious cardio-pulmonary condition,” said Martine Rothblatt, PhD, United Therapeutics’ Chairman and CEO.
In the TRIUMPH-1 randomized, double-blind, 12-week, placebo-controlled clinical trial, patients taking treprostinil in four daily inhalation sessions achieved a 20-meter improvement in six-minute walk distance compared with placebo recipients.
The safety and effectiveness in patients with underlying lung disease has not been established. The most common side effects seen with treprostinil were cough, headache, nausea, dizziness, flushing, throat irritation, pharyngolaryngeal pain, and diarrhea.