United Therapeutics PAH drug wins approval

FDA approves Orenitram

SILVER SPRING, Md. — The Food and Drug Administration has approved a new drug made by United Therapeutics for treating pulmonary arterial hypertension, the company said Monday.

The FDA approved Orenitram (treprostinil) extended-release tablets for treating certain PAH patients to improve exercise capacity. PAH is a disease in which abnormally high blood pressure in the arteries of the lungs causes the right side of the heart to work harder than normal, according to the National Library of Medicine.

"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," United Therapeutics president and COO Roger Jeffs said. "We are grateful for the FDA's thorough review and will continue to build clinical support for the use of Orenitram."


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