The French regulator, Agence Francaise de Securite Sanitaire des Produits de Sante (AFSSAPS), has cleared United Therapeutics’ prostacyclin vasodilator Remodulin for intravenous use in the treatment of pulmonary arterial hypertension (PAH). The drug had previously been approved in most of Europe as a continuous subcutaneous infusion to improve exercise tolerance and symptoms in patients with idiopathic or heritable PAH.
French agency clearance of the intravenous administration indication follows a review period during which 22 EU member states endorsed the final variation assessment report issued by AFSSAPS. This means that these nations will also allow the intravenous route of Remodulin delivery.
United Therapeutics in addition confirmed that it has submitted an NDA requesting clearance of its sustained-release oral tablet formulation of the compound for the treatment of PAH. The drug is separately available in the U.S. as Tyvaso as an inhaled liquid formulation for increasing exercise tolerance in PAH patients.
United Therapeutics reported total Remodulin revenues of just under $115,000 in the three months ending September 30, up 4.9% on the equivalent 2010 period. Tyvaso revenues were up 36.2% at $66,330.