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FDA Approves Iloprost for the Treatment of Pulmonary Arterial Hypertension
"This approval provides PAH patients with a non-invasive treatment option that avoids the complications associated with intravenous or subcutaneous prostacyclin delivery," said Donald J. Santel, Chief Executive Officer of CoTherix, Inc. "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, M.D., Professor of Medicine and Director, Pulmonary Hypertension Program at University of California, San Diego. "We commend the efforts of CoTherix to make a non-invasive therapeutic option available to the PH community."
"We are excited that, with the approval of Ventavis, physicians have a new option for treatment," said Rino Aldrighetti, President of the Pulmonary Hypertension Association. "Hope for patients with this difficult and often misdiagnosed illness is growing."
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.
A randomized, double-blind, multi-center, placebo-controlled trial was conducted in 203 adult patients (inhaled Ventavis: n=101; placebo: n=102) with NYHA Class III or IV pulmonary arterial hypertension (PAH, WHO Group I; idiopathic in 53%, associated with connective tissue disease, including CREST and scleroderma, in 17%, or associated with anorexigen use in 2%) or pulmonary hypertension related to chronic thromboembolic disease (WHO Group IV; 28%). The primary clinical endpoint for the trial was a composite of: (1) an improvement in NYHA functional class, (2) an increase in the distance walked in six minutes of at least 10%, and (3) no clinical deterioration or death. The response rate for the primary efficacy endpoint among PAH patients was 19% for patients treated with Ventavis, compared with 4% for the placebo-treated patients (p=0.0033). All three components of the composite endpoint favored Ventavis. The absolute change in 6-minute walk distance measured 30 minutes after inhalation among patients with PAH was greater in the Ventavis group compared to the placebo group at all time points, including week 12, with a placebo-corrected difference of 40 meters (p
Ventavis Safety Profile
Ventavis is generally well tolerated. The most common side effects with Ventavis include reddening of the face caused by dilation of blood vessels (flushing), increased cough, low blood pressure (hypotension), headaches, nausea, spasm of the jaw muscles that causes trouble opening your mouth, and fainting (syncope). Other serious adverse events reported with the use of inhaled Ventavis include: congestive heart failure, chest pain, supraventricular tachycardia, dyspnea, peripheral edema, and kidney failure.
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. Symptoms of the disease include fatigue, shortness of breath on exertion, chest pain and dizziness. Left untreated, the median survival time following diagnosis may be as short as three years.
Source: CoTherix, Inc.