FDA approves brand name for Actelion's PAH drug as Veletri; PAH registry now enrolling patients

The US subsidiary of Switzerland-based Actelion, Europe's largest biotechnology firm, says that the US Food and Drug Administration has approved the brand name Veletri for the company's epoprostenol for injection therapy.

The drug has been commercially available since April this year as Epoprostenol for Injection for the treatment of moderate to severe pulmonary arterial hypertension and PAH associated with the scleroderma spectrum of disease. Actelion plans to release Veletri-labeled product by early fourth quarter of 2010.

Veletri is an improved formulation of epoprostenol that offers greater convenience to patients than other epoprostenol formulations. It is stable at room temperature for up to 24 hours when diluted as directed and put into the pump for administration, eliminating the need for ice packs, the company notes.