InterMune has submitted a Marketing Authorization Application (MAA) seeking approval of pirfenidone for the treatment of idiopathic pulmonary fibrosis (IPF) in adults, which was validated by the European Medicines Agency (EMA) effective March 24, 2010. Validation of the MAA by the EMA indicates that the application is complete and that the review process has begun.
IPF is a rare and fatal lung disease that affects approximately 200,000 people in the United States and Europe combined. If approved by the EMA, pirfenidone would be the first medication to be made available to IPF patients in the European Union. Pirfenidone has been granted Orphan Drug designation in Europe.
Preclinical and in-vitro evidence has shown that pirfenidone has both anti-fibrotic and anti-inflammatory effects. In February 2009, InterMune announced the results of the company's two global Phase 3 clinical trials evaluating pirfenidone for the treatment of IPF, known as the CAPACITY trials. Prior to the CAPACITY results, Shionogi & Co. Ltd (Shionogi) had presented data from a Phase 3 study conducted in Japan which demonstrated that pirfenidone reduced the decline in lung function and improved progression-free survival in patients with IPF. In this clinical study, pirfenidone was safe and generally well-tolerated, with the most frequent side effects reported being photosensitivity rash and gastrointestinal symptoms. In October of 2008, pirfenidone was approved for use in IPF patients in Japan and is marketed as Pirespa® by Shionogi in that country.
InterMune is a biotechnology company focused on the research, development and commercialization of innovative therapies in pulmonology and hepatology.
|SOURCE InterMune, Inc.|
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