InterMune, Inc. announced that NASDAQ has today halted trading of InterMune's common stock. The Pulmonary-Allergy Drugs Advisory Committee (PADAC) to the U.S. Food and Drug Administration (FDA) meets today to review and discuss the company's New Drug Application (NDA) for pirfenidone for the treatment of patients with idiopathic pulmonary fibrosis (IPF).
Pirfenidone Regulatory Path - NDA and MAA
On November 4, 2009, InterMune submitted the NDA for pirfenidone to the FDA, seeking approval to market pirfenidone to reduce decline in lung function in patients with IPF. Pirfenidone has been granted Orphan Drug and Fast Track designation by the FDA, and also has been granted Orphan Drug status in Europe. On January 4, 2010, InterMune announced that the FDA granted Priority Review designation for the pirfenidone NDA. Priority Review designation may be granted by the FDA to an NDA for drugs that have the potential to offer major advances in treatment, or provide a treatment where no adequate therapy exists. Based on the Prescription Drug User Fee Act (PDUFA), the FDA has set an action date for the NDA of May 4, 2010.
On March 2, 2010, InterMune announced that it had submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA), seeking approval to market pirfenidone for the treatment of IPF patients in the European Union.