The US Food and Drug Administration’s Pulmonary-Allergy Drugs Advisory Committee (PADAC) voted 9 to 3 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 affects approximately 200,000 people in the
The Advisory Committee’s recommendations are not binding, but they will be considered as the FDA completes its review of the New Drug Application (NDA) for Esbriet. The company will be working closely with the FDA during the review period, says Dan Welch, chair, CEO, and president of InterMune. The drug received Orphan Drug, Fast Track, and Priority Review designation by the FDA.Priority Review designation is granted to an NDA for drugs that have the potent ional to offer major advances in treatment, or provide a treatment where no adequate therapy exists, according to a press release from InterMune.
A target date of May 4, 2010 has been set under the Prescription Drug User Fee Act (PDUFA).