InterMune, Inc. (Nasdaq: ITMN) announced today that the U.S. Food and Drug Administration (FDA) has posted briefing documents for the March 9 Pulmonary-Allergy Drugs Advisory Committee (PADAC) meeting to review the New Drug Application (NDA) for pirfenidone, InterMune's investigational drug candidate for the treatment of patients with idiopathic pulmonary fibrosis (IPF) to reduce decline in lung function. The proposed trade name for pirfenidone is Esbriet®.
IPF is a disabling and ultimately fatal disease that affects approximately 200,000 people in the United States and Europe combined, with approximately 30,000 new cases reported per year in each region. There are no medicines approved in the United States or in Europe for the treatment of IPF. Pirfenidone was approved in Japan in October of 2008 and is marketed by Shionogi & Co. Ltd as Pirespa®.
The Advisory Committee meeting is scheduled for 8:00 a.m. EST on Tuesday, March 9, 2010. The briefing materials can be accessed at: http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/Pulmonary-AllergyDrugsAdvisoryCommittee/ucm199877.htm
Pirfenidone Regulatory Path – NDA and MAA