FDA Advisory Committee Recommends Approval of Esbriet (pirfenidone)

InterMune, Inc., Brisbane, Calif., announced today 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 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 FDA completes its review of the New Drug Application (NDA) for Esbriet. Esbriet received Orphan Drug, Fast Track and Priority Review designations by the 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).

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 Esbriet for the treatment of IPF patients in the European Union. Esbriet (pirfenidone) has been granted Orphan Drug status in Europe.

Date: March 9, 2010
Source: InterMune