InterMune, Inc 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. "This 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 US market.
Preclinical and in-vitro evidence has shown that pirfenidone has both anti-fibrotic and anti-inflammatory effects.
Idiopathic pulmonary fibrosis (IPF) is a disabling and ultimately fatal disease that affects approximately 200,000 people in Europe and the United States combined, with approximately 30,000 new cases reported per year in each region.
InterMune is a biotechnology company focused on the research, development and commercialization of innovative therapies in pulmonology and hepatology.