United Therapeutics Corporation announced today that the U.S. Food and Drug Administration (FDA) has issued an approval letter for the intravenous use of Remodulin based on data establishing its bioequivalence with the previously approved subcutaneous administration of Remodulin.
As a result of this approval of United Therapeutics' supplemental New Drug Application that was filed ten months ago, Remodulin is immediately available for commercial intravenous use.
The new label indicates that Remodulin (treprostinil sodium) Injection is now approved as a "continuous subcutaneous infusion or intravenous infusion (for those not able to tolerate a subcutaneous infusion) for the treatment of pulmonary arterial hypertension in patients with NYHA Class II-IV symptoms to diminish symptoms associated with exercise." The complete expanded label is posted at http://www.unither.com/.
"It gives us great satisfaction to make available this new route of delivery for our prostacyclin analog, Remodulin," said Martine Rothblatt, Ph.D., United Therapeutics' Chairman and CEO. "Intravenous Remodulin adds another option for pulmonary hypertension patients," added Dr. Rothblatt.
"Just over sixteen months ago we conceived of using bioequivalence as the clinical pathway to regulatory approval for intravenous Remodulin," said Roger A. Jeffs, Ph.D., United Therapeutics' President and Chief Operating Officer. "It is a remarkable testament to the FDA's responsiveness, and to our clinical development team's proficiency, that we have achieved authorization in so brief a period of time," concluded Dr. Jeffs.