InterMune, Inc. (Nasdaq: ITMN) today announced that it has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) seeking approval to market pirfenidone for the treatment of patients with idiopathic pulmonary fibrosis (IPF) in the European Union (EU). Currently, there are no EMA-approved treatments for IPF in the EU.
"IPF is a debilitating and universally fatal disease that affects as many Europeans as Americans," said Dan Welch, Chairman, Chief Executive Officer and President of InterMune. "Today's MAA submission marks an important first step toward making the first IPF treatment available to patients in Europe. It also represents an important milestone for InterMune, demonstrating our commitment to developing and commercializing new treatments for unmet medical needs, including advancing care for patients with this devastating disease."
InterMune currently expects the validation process by the EMA to be completed by late March. Validation of the MAA indicates that InterMune's application is complete and that the review process has begun.
Pirfenidone has been granted Orphan Drug designation in Europe. If approved by the EMA, InterMune currently plans to commercialize pirfenidone independently in Europe and is prepared to expand its commercial infrastructure to support European marketing efforts. Given the significant unmet medical need, the approval of pirfenidone in Europe would represent a second and important value-creation opportunity to that represented by the U.S. market.