United Therapeutics Gains FDA Approval For Orenitram

(RTTNews) - Drug manufacturer United Therapeutics Corp. (UTHR), said its Orenitram (treprostinil) Extended-Release Tablets, gained FDA approval for the treatment of pulmonary arterial hypertension in WHO Group I patients to improve exercise capacity.

The primary efficacy study, FREEDOM-M, showed that patients receiving Orenitram twice daily improved their median six-minute walk distance compared with those on placebo.

"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, President and Chief Operating Officer.