US FDA clears new formulation of Actelion's Ventavis

Actelion, a major European biotechnology firm based in Switzerland, says that the US Food and Drug Administration has approved a new 20 microgram per milliliter (mcg/ml) formulation of Ventavis (iloprost) as a therapy for New York Heart Association Class III and IV pulmonary arterial hypertension (PAH). This new increased 20 mcg/ml strength formulation will deliver the same dose in half the volume which is expected to reduce inhalation time and further support patient compliance, the company noted.

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.

Harold Palevsky, professor of medicine at the University of Pennsylvania School of Medicine, Chief of the Pulmonary, Allergy and Critical Care Division, and Director of the Pulmonary Vascular Disease Program at Penn Presbyterian Medical Center in Philadelphia in the USA, commented: "Ventavis is an important treatment option for many patients with PAH. Decreasing the time required per inhalation will allow these patients more time to focus on activities that are important in their lives. In addition, the new formulation should help maintain patient compliance, an important part of any PAH therapy"

In January 2007, Actelion announced the successful completion of its cash tender offer for shares of CoTherix, thereby strengthening its PAH franchise by adding Ventavis to its product offerings in theUSA. Bayer Schering Pharma - the inventor of Ventavis - markets the drug as the first inhaled prostacyclin in Europe and other countries outside the USA.