According to a BioSpace report, the French regulatory agency Agence Francaise de Securite Sanitaire des Produits de Sante (AFSSAPS) has approved intravenous (IV) use of treprostinil (Remodulin™) for the treatment of pulmonary arterial hypertension (PAH).

Treprostinil 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 risk management plans (RMPs) for treporostinil will focus on minimising the known risks of central venous catheter-related blood stream infections associated with IV administration.

[Note: Treprostinil is not a licensed product in the UK.]