Silver Spring-based United Therapeutics Corporation (NASDAQ: UTHR) continues to expand into new markets with the French regulatory agency approval of the Intravenous form of its Pulmonary Arterial Hypertension drug Remodulin.
The Agence Francaise de Securite Sanitaire des Produits de Sante (AFSSAPS) is the France regulatory agency equivalent to the United States' Food and Drug Administration. 22 European member nations have already approved Remodulin for sale and use, the approval by France opens one the largest markets in Europe to United Therapeutics.
United Therapeutics Europe, Ltd., is the European subsidiary of the D.C. areas largest biotech measured by market value and will be in charge of selling and marketing Remodulin also known as treprostinil.
"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."