On Dec. 29, the FDA approved iloprost inhalation solution (Ventavis, made by CoTherix, Inc.), for the treatment of pulmonary arterial hypertension (PAH) in patients with New York Heart Association (NYHA) Class III or IV symptoms.
The synthetic prostacyclin analog is intended for administration with Prodose Adaptive Aerosol Delivery (AAD) system. According to a company news release, the non-invasive nature of the system is expected to increase patient compliance and avoid complications associated with intravenous or subcutaneous prostacyclin delivery.
The approval was based on the results of a controlled trial comparing the effects of repeated daily inhalations of iloprost (2.5- or 5.0-micrograms 6 to 9 times daily) with placebo in 203 adult patients with selected forms of severe PAH and chronic thromboembolic pulmonary hypertension, NYHA functional class III or IV. The median inhaled dose of iloprost was 30 micrograms/day.
At three months, 16.8% of patients receiving iloprost showed significant improvement in symptoms (at least one NYHA class), and exercise tolerance (minimum 10% increase in six-minute walking distance), compared with 4.9% of patients receiving placebo ( P = .0033).
Iloprost was generally well tolerated. The most commonly reported adverse events included flushing, increased cough, hypotension, headaches, nausea, trismus, and syncope.
Iloprost inhalation solution was previously approved for this indication in several European countries and Australia, where it is marketed by Schering AG.
by Yael Waknine
FDA Approvals: Ventavis, Kepivance, Captique