Actelion Gets FDA Approval For Ventavis In Increased Strength Formulation

FDA has approved Actelion’s new 20mcg/ml formulation of Ventavis as a therapy for New York Heart Association Class III and IV pulmonary arterial hypertension (PAH). The new increased 20mcg/ml strength formulation is said to deliver the same dose in half the volume, which is expected to reduce inhalation time and further support patient compliance.

The approval was based on the submission of technical data, showing that the new formulation did not alter the functional characteristics of the delivery system or the emitted dose to the patient.

Jean-Paul Clozel, MD and chief executive officer of Actelion, said: “This is another major improvement for Ventavis in the US and for the patients who use this important inhaled therapy for PAH. The only inhaled prostacyclin therapy to show significant patient improvement measured by both exercise capacity and improvement in NYHA Functional Class. In 2008, Actelion successfully implemented an improved cleaning protocol for the device which significantly reduced the time each patient spent on maintenance.

“We have now been successful with this new strengthened formulation offering additional convenience for US patients using Ventavis. We will continue our commitment to Ventavis as well as our portfolio of PAH programs in order to achieve further improvements for the PAH community,” he added.