The approval covers Remodulin (treprostinil sodium) injection for subcutaneous treatment of class III primary pulmonary hypertension patients. The approval letter did not request any additional clinical trials of subcutaneous Remodulin.
“We are very pleased to receive this approval,” said Dr Roger Jeffs, United Therapeutics’ president and COO. “We expect to receive mutual recognition in the remainder of the European Union based on the French label.”
“France is globally recognized as having some of the most preeminent leaders in the diagnosis and treatment of pulmonary hypertension,” added Dr Martine Rothblatt, chairman and CEO. “Hence, we feel especially honored to provide the opportunity to add Remodulin to the armamentarium of French physicians, and following mutual recognition, other European physicians in tackling primary pulmonary hypertension.”
AFSSAPS has indicated that the mutual recognition approval process with other countries in the EU will be initiated in May 2005.