InterMune’s Esbriet (pirfenidone) has become the first treatment approved in the EU to treat idiopathic pulmonary fibrosis (IPF), a progressive and fatal lung disease.
The European Commission decision to grant a marketing authorisation to the drug has been described as a “landmark event in IPF care”.
Esbriet has also been granted Orphan Drug designation, which provides 10 years of marketing exclusivity in the EU lasting until 2021. InterMune intends to launch the product in Germany this September, in France, Spain and Italy in early 2012 and the UK in mid-2012.
Roland du Bois, MD, Professor of Respiratory Medicine, Imperial College, 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.”
The conditions of the approval include a commitment by the company to monitor adverse drug reactions (ADRs) and to conduct a PASS (Post Authorization Safety Study) in the form of a registry to systematically collect and monitor ADRs.
Dan Welch, Chairman, Chief Executive Officer and President of InterMune, said: “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 organisation. Our seasoned leadership team in the EU is working very diligently to make Esbriet available to European patients as soon as possible.”
More than 100,000 patients suffer from IPF in the 10 most-populated European countries.