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European Regulators Grant Sildenafil Orphan Drug Designation for Possible Treatment of Pulmonary Arterial Hypertension
PAH is a rare and potentially fatal disease. It is characterized by abnormally high blood pressures in the arteries of the lungs. Patients with PAH often become short of breath after physical exertion and the disease leads to heart failure. PAH affects two people in ten thousand but is two to three times more common in women than men and often strikes women during their child-bearing years. Left untreated, PAH will significantly reduce life expectancy.
"We are pleased with the EC's decision to grant sildenafil orphan drug status," said Joseph Feczko, M.D., President Worldwide Development. "If the results of clinical trials using sildenafil to treat PAH are positive, we will move forward with the drug registration process. There is a clear need for new treatment options for patients suffering from this deadly disease."
Currently, Pfizer is conducting Phase III studies using sildenafil, with results expected by mid-year. A sildenafil product for use in PAH would be marketed under a different name than Viagra.
The European Commission designates orphan drug status to medicinal products that treat life threatening conditions that affect fewer than five in 10,000 people and where the drug provides significant benefit over existing approved therapy. Orphan drug status allows for 10-year market exclusivity and restricts approval of similar products for the same indication over the exclusivity period.
Viagra is available only from health care providers and should always be used in accordance with its approved labeling. Viagra is contraindicated in patients who use nitrates in any form at any time.