FDA grants Priority Review designation for InterMune's NDA for pirfenidone

Jan 4 2010

InterMune, Inc. (Nasdaq: ITMN) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review and granted Priority Review designation for the company's New Drug Application (NDA) for pirfenidone for the treatment of patients with idiopathic pulmonary fibrosis (IPF).

Priority Review designation may be granted by the FDA to an NDA for drugs that offer major advances in treatment, or provide a treatment where no adequate therapy exists. This designation has the potential to expedite the NDA approval process by reducing the target review period for the application from approximately 10 months to six months. Based on the Prescription Drug User Fee Act (PDUFA), the FDA has set an action date for the NDA of May 4, 2010.

Dan Welch, Chairman, Chief Executive Officer and President of InterMune, said, "We are pleased to have begun the review process of the first NDA submitted to FDA for a medicine for IPF patients and we look forward to working with the Pulmonary-Allergy Division to complete the review as expeditiously and thoughtfully as possible."