United Therapeutics Corporation (NASDAQ: UTHR) announced today that the United States Food and Drug Administration (FDA) has approved Orenitram (treprostinil) Extended-Release Tablets for the treatment of pulmonary arterial hypertension (PAH) in WHO Group I patients to improve exercise capacity.
"This approval marks the first time that the FDA has approved an orally administered prostacyclin analogue for any disease – and our fifth approval from the FDA for treatment of PAH – supporting our mission of providing a wider choice of PAH therapies for physicians and patients," said Roger Jeffs, Ph.D., United Therapeutics' President and Chief Operating Officer. "We are grateful for the FDA's thorough review and will continue to build clinical support for the use of Orenitram."
The primary efficacy study, FREEDOM-M, demonstrated that patients receiving Orenitram twice daily (BID) improved their median six-minute walk distance (6MWD) by +23 meters [p=0.013] as compared to patients receiving only placebo. As the sole vasodilator, the effect of Orenitram on exercise is small and Orenitram has not been shown to add to other vasodilator therapy. Two other Phase 3 studies (FREEDOM-C and FREEDOM-C2) did not demonstrate a benefit in exercise with median 6MWD at Week 16 (11 meters [p=0.072] and 10 meters [p=0.089], respectively).
The most common side effects reported in the clinical studies with Orenitram (placebo-corrected incidence >10%) are headache, nausea, and diarrhea.
Orenitram is dosed twice a day with food, but the total daily dose can be divided and given three times daily with food. Orenitram is available in four strengths: 0.125 mg, 0.25 mg, 1 mg and 2.5 mg. The dose of Orenitram should be increased as tolerated to achieve optimal clinical response. The maximum dose is determined by tolerability.
United Therapeutics Corporation