Biopharmaceutical company Actelion has received approval from the US Food and Drug Administration (FDA) for an increased-strength dose of Ventavis as a treatment for pulmonary arterial hypertension (PAH).
The increased 20mcg/ml strength formulation will reduce inhalation time and further support patient compliance by delivering the same dose in half the volume.
The approval was based on technical data, which showed that the new formulation did not alter the functional characteristics of the delivery system or the emitted dose to the patient.
Actelion MD and chief executive officer Jean-Paul Clozel said that this was a major improvement for the patients who use this important inhaled therapy.
“Ventavis is the only inhaled prostacyclin therapy to show significant patient improvement measured by exercise capacity and improvement in New York Heart Association Class III and IV PAH,” Clozel said.