United Therapeutics Corporation, a biotechnology company focused on combating chronic and life-threatening cardiovascular, infectious and oncologic diseases with unique therapeutic products, reported that the U.S. Food and Drug Administration (FDA) has approved Remodulin (treprostinil sodium) Injection as a continuous subcutaneous infusion for the treatment of pulmonary arterial hypertension in patients with NYHA Class II-IV symptoms to diminish symptoms associated with exercise.

The FDA approved Remodulin under its accelerated approval regulations based on the largest double blind placebo-controlled study ever conducted in pulmonary arterial hypertension, a disease in which blood pressure in the pulmonary arteries rises to life-threatening levels. In clinical trials, the most common side effects reported with Remodulin therapy included infusion site pain (85%) and infusion site reaction (83%). Other adverse events included headache (27%), diarrhea (25%), nausea (22%), rash (14%), jaw pain (13%), vasodilatation (11%), dizziness (9%), edema (9%), pruritus (itching) (8%) and hypotension (4%). Remodulin should be used only by clinicians experienced in the diagnosis and treatment of PAH.

Approximately 500 pulmonary arterial hypertension patients worldwide continue to use Remodulin in open label studies sponsored by United Therapeutics, with some patients on the drug for nearly four years.

Approximately 50,000 people in North America and Europe are estimated to be afflicted with NYHA Class II-IV forms of the disease, most of whom are undiagnosed.

"We are pleased that our constructive work with the FDA has resulted in the approval of Remodulin for all symptomatic stages of the disease, including the first approved therapy for NYHA Class II pulmonary arterial hypertension patients," said Roger Jeffs, Ph.D., president and chief operating officer of United Therapeutics. "We are committed to continuing clinical trials to further evaluate the benefit of Remodulin in the treatment of this devastating condition. We are grateful to the patients and investigators who have made this approval possible."

"There is a tremendous need to provide expanded treatment options to these patients and the approval of Remodulin is very encouraging news for patients and physicians alike," said Dr. Stuart Rich, professor of medicine and director, Rush Heart Institute Center for Pulmonary Heart Disease at Rush Presbyterian St. Luke's Hospital and a member of the Remodulin trial steering committee.

United Therapeutics has submitted Remodulin marketing applications to health authorities in France, Switzerland and Canada. Additional international filings will follow approval in the U.S. and France. United Therapeutics has also formed Remodulin distribution partnerships in Europe, Canada, Australia, Latin America and Israel.

United Therapeutics agreed as a condition of approval to conduct a post- approval controlled clinical trial to verify and further describe Remodulin's clinical benefits. United Therapeutics will conduct a randomized transition of patients treated with Flolan -- a synthetic form of prostacyclin delivered intravenously -- to either subcutaneous Remodulin or placebo. Outcome measures will include clinical deterioration, PAH symptoms and exercise performance.