InterMune, Inc announced that the US Food and Drug Administration's (FDA) Pulmonary-Allergy Drugs Advisory Committee (PADAC) voted 9-3 to recommend approval of Esbriet (pirfenidone) for the treatment of patients with idiopathic pulmonary fibrosis (IPF) to reduce decline in lung function.

IPF is a rare and fatal lung disease that affects approximately 200,000 people in the United States and Europe. If approved by the US FDA for commercialization, Esbriet would be the first medication to be made available to IPF patients in the United States.

"We are pleased with the outcome of today's Advisory Committee meeting," said Dan Welch, chairman, chief executive officer and president of InterMune. "We look forward to working closely with the FDA as review of the Esbriet NDA continues."

Though the Advisory Committee's recommendations are not binding, they will be considered as the US FDA completes its review of the New Drug Application (NDA) for Esbriet. Esbriet received Orphan Drug, Fast Track and Priority Review designations by the US FDA. 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. A target date of May 4, 2010 has been set under the Prescription Drug User Fee Act (PDUFA).

Preclinical and in-vitro evidence has shown that Esbriet has both anti-fibrotic and anti-inflammatory effects.

InterMune is a biotechnology company focused on the research, development and commercialization of innovative therapies in pulmonology and hepatology.