The US FDA has approved Ventavis (iloprost) Inhalation Solution for the treatment of pulmonary arterial hypertension (PAH) in patients with NYHA Class III or IV symptoms, following priority review, CoTherix, Inc. announced here. PAH is a highly debilitating and potentially fatal disease characterized by high blood pressure in the pulmonary arteries of the lungs.
"This approval provides PAH patients with a non-invasive treatment option that avoids the complications associated with intravenous or subcutaneous prostacyclin delivery," Donald J. Santel, chief executive officer of CoTherix, Inc said adding, "We intend to launch Ventavis through our own direct sales force to make it broadly available to the PAH community in the United States."
"Making therapy easier to administer is critical to enhancing patient compliance and improving management of the disease," said Lewis J. Rubin, professor of medicine and director, Pulmonary Hypertension Programme at University of California, San Diego. "We commend the efforts of CoTherix to make a non-invasive therapeutic option available to the PH community," he added.
Ventavis is currently marketed by Schering AG in several European countries and Australia. CoTherix licensed exclusive rights to develop and commercialize Ventavis in the United States from Schering AG in October 2003 and filed a New Drug Application (NDA) in June 2004. In August 2004, CoTherix's NDA was accepted by the FDA and granted priority review. In addition, Ventavis received orphan drug designation in August 2004 to treat PAH.
PAH affects an estimated 50,000 patients in the United States, with only about 15,000 diagnosed and under treatment. Its cause may be unknown, or result from other diseases that cause a restriction of blood flow to the lungs, including scleroderma, HIV and lupus.