March 10, 2010: The FDA’s Pulmonary-Allergy Drugs Advisory Committee (PADAC) has voted to recommend approval of InterMune’s 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 about 200,000 people in the USA and Europe. If approved by the FDA for commercialisation, Esbriet would be the first medication to be made available to IPF patients in the USA.
Though the Advisory Committee’s recommendations are not binding, they will be considered as the FDA completes its review of the NDA for Esbriet. The drug has 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).
Last week, InterMune announced that it had submitted a Marketing Authorization Application to the European Medicines Agency seeking approval to market Esbriet for the treatment of IPF patients in the EU. Esbriet has been granted Orphan Drug status in Europe.
