EU Commission OKs InterMune's Esbriet and self-admin label for Shire's Firazyr

In a batch of new drug approvals, the European Commission provided a boost to InterMune and Shire clearing the companies’ product for marketing in the European Union. The EC also backed continued use of Roche’s Avastin fore metastatic breast cancer.

Switzerland-based InterMune (Nasdaq: ITMN) was granted marketing authorization for Esbriet (pirfenidone), 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 more than 100,000 patients suffering from IPF in Europe, says the company, whose shares rose 2.8% to $38.20 in pre-market trading yesterday.

Dan Welch, chairman, chief executive and president of InterMune, said: “The approval of Esbriet not only marks an historic moment in the treatment of IPF patients, who previously had no approved medicines to help them manage the disease, but also an exciting new chapter for our company as we now transition to become an international commercial organization.”