FDA approves brand name VELETRI for Actelion's epoprostenol for injection therapy

Aug 26 2010

Actelion Pharmaceuticals US, Inc., today announced that the U.S. Food and Drug Administration (FDA) has approved the brand name VELETRI® for the company's epoprostenol for injection therapy.  VELETRI has been commercially available since April 2010 as Epoprostenol for Injection for the treatment of moderate to severe pulmonary arterial hypertension (PAH) 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.  VELETRI 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.

"VELETRI is a proven therapy for the treatment of PAH patients who don't respond adequately to conventional treatment, and rounds out a portfolio of therapies designed to address the diverse needs of patients with this chronic and life-threatening disease," said Shal Jacobovitz, president of Actelion Pharmaceuticals US, Inc.  "As the pioneer in PAH, we are committed to transforming the lives of patients by developing efficacious therapies that also offer flexibility and convenience in treatment."

In conjunction with the launch of VELETRI, Actelion opened its fourth PAH patient registry in the United States.  PROSPECT, the registry to PROSPECTively evaluate use of VELETRI in patients with PAH, is a multicenter, observational, U.S.-based registry, which is currently ongoing.

Actelion will also provide further information on VELETRI at the American Heart Association Scientific Sessions 2010 in Chicago with a poster entitled "Biocomparability of Two Formulations of Epoprostenol, Epoprostenol for Injection (ACT-385781A) And Flolan®, Via Pharmacokinetic Assessment of Two Primary Metabolites."

The registration process for Epoprostenol for Injection is ongoing outside the US, initially in France, also with VELETRI as proposed brand name.