French Regulator Clears United Therapeutics’ Remodulin for PAH Therapy
The clearance follows a review period during which 22 EU member states endorsed the final variation assessment report issued by AFSSAPS.
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.
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