|NEWSRoom | Source: InterMune, Inc.|
InterMune Receives European Union Approval for Esbriet® (pirfenidone)
InterMune, Inc. announced that the European Commission (EC) has granted marketing authorization for Esbriet® (pirfenidone). Esbriet is indicated in adults for the treatment of mild to moderate idiopathic pulmonary fibrosis (IPF), a progressive and fatal lung disease. The approval authorizes marketing of Esbriet in all 27 EU member states, and marks a significant turning point for the treatment of IPF patients in Europe. More than 100,000 patients suffer from IPF in the 10 nations that comprise the most-populated European countries; approximately 87,000 patients in the five largest countries of Germany, France, Spain, Italy and the United Kingdom.
“InterMune is proud to bring the first IPF medicine, Esbriet, to patients in Europe,” said Dan Welch, Chairman, Chief Executive Officer and President of InterMune. “We are very pleased with our approved label for Esbriet and believe it will effectively support the access, pricing, reimbursement and marketing of Esbriet in Europe. The approval of Esbriet not only marks an historic moment in the treatment of IPF patients, but also an exciting new chapter for our company as we now transition to become an international commercial organization. Our seasoned leadership team in the EU is working very diligently to make Esbriet available to European patients as soon as possible, beginning with Germany in September of this year.”
Based on anticipated EU country reimbursement timelines, InterMune currently plans to launch Esbriet in the so-called “Top 5” EU countries as follows: Germany in September of 2011; France, Spain and Italy in the first half of 2012 and in the United Kingdom in mid-2012. InterMune also plans to launch Esbriet in all or substantially all of the 10 most important pharmaceutical markets in the EU by approximately mid-2012.
Roland du Bois, MD, Professor of Respiratory Medicine, Imperial College, London, and co-chair of the Esbriet Phase 3 clinical program, said, “IPF is a chronic, progressive, respiratory disease with an estimated survival rate of only 20% after five years, which makes it more lethal than many cancers, and yet no therapeutic interventions have been approved for European patients suffering from this devastating disease—until today. The approval of this new medicine for European patients is a landmark event in IPF care, as Esbriet now offers individuals suffering from this appalling disease a novel treatment that has been shown to have a clinically meaningful effect in their disease.”
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