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Pirfenidone Granted Priority Review by FDA
Priority Review designation may be granted by the FDA to an NDA for drugs that offer major advances in treatment, or provide a treatment where no adequate therapy exists. This designation has the potential to expedite the NDA approval process by reducing the target review period for the application from approximately 10 months to six months. Based on the Prescription Drug User Fee Act (PDUFA), the FDA has set an action date for the NDA of May 4, 2010.
Dan Welch, Chairman, Chief Executive Officer and President of InterMune, said, "We are pleased to have begun the review process of the first NDA submitted to FDA for a medicine for IPF patients and we look forward to working with the Pulmonary-Allergy Division to complete the review as expeditiously and thoughtfully as possible."
Preclinical and in-vitro evidence had shown that pirfenidone has both anti-fibrotic and anti-inflammatory effects. Results from three adequate and well-controlled Phase 3 studies have shown evidence of a treatment effect in IPF patients and the compound has been safe and generally well tolerated, with the most common side effects including photosensitivity rash and gastrointestinal symptoms.
Idiopathic pulmonary fibrosis (IPF) is a disabling and ultimately fatal disease that affects approximately 200,000 patients in the United States and Europe combined, with approximately 30,000 new cases reported per year in each of the United States and Europe.
IPF is characterized by inflammation and scarring (fibrosis) in the lungs, hindering the ability to process oxygen and causing shortness of breath (dyspnea) and cough and is a progressive disease, meaning that over time, lung scarring and symptoms increase in severity. The median survival time from diagnosis is two to five years, with a five-year survival rate of approximately 20%. Patients diagnosed with IPF are usually between the ages of 40 and 70, with a median age of 63 years and the disease tends to affect slightly more men than women. There are no medicines approved in the United States or Europe for the treatment of IPF.