SILVER SPRING, Md. and CHERTSEY, England, Dec. 27, 2011 /PRNewswire/ -- United Therapeutics Corporation (NASDAQ: UTHR) and its wholly-owned subsidiary, United Therapeutics Europe, Ltd., announced today that the French regulatory agency Agence Francaise de Securite Sanitaire des Produits de Sante (AFSSAPS) has approved intravenous use of Remodulin® (treprostinil) for the treatment of pulmonary arterial hypertension (PAH). Remodulin is already approved in most of Europe for the continuous subcutaneous infusion treatment of idiopathic or heritable PAH to improve exercise tolerance and symptoms of the disease in patients classified as New York Heart Association (NYHA) functional class III. The AFSSAPS' approval follows a review period during which 22 European member nations, each of which had previously approved subcutaneous Remodulin through the mutual recognition process, reviewed and endorsed the final variation assessment report (FVAR) issued by AFSSAPS, which will allow the use of the intravenous route of delivery to the Remodulin in the labeling in those nations.
"It is with great satisfaction that intravenous use of Remodulin will now be available to PAH patients in Europe," said Roger A. Jeffs, Ph.D., President and Chief Operating Officer. "This approval significantly expands the treatment options for PAH patients using parenteral therapy in Europe."
In Europe, risk management plans (RMPs) are routinely required as part of the regulatory approval process for new medicines and also for significant variations involving a change to the route of administration, formulation or indication. For intravenous Remodulin, United Therapeutics will implement an RMP focused on minimizing the known risks of central venous catheter-related blood stream infections associated with intravenous administration.
Oral Treprostinil New Drug Application Submitted to the FDAUnited Therapeutics also announced today that it submitted to the U.S. Food and Drug Administration a New Drug Application (NDA) for treprostinil diethanolamine sustained release tablets (oral treprostinil) for the treatment of PAH on December 27, 2011. The submission starts a 60-day period during which the FDA will examine the application for completeness. If the FDA accepts the NDA for review, then it is expected to be subject to the standard review period of 10 months from the submission date, before an action letter is issued.
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