Positive Ph III results with InterMune's pirfenidone

Phase III trials, demonstrating that treatment with US biotech firm InterMune’s (Nasdaq: ITMN) pirfenidone, a novel antifibrotic and anti-inflammatory drug, was associated with favorable effects on lung function, six-minute walk test distance and progression-free survival (PFS) in patients with mild to moderate idiopathic pulmonary fibrosis (IPF), have been published in the on-line version to the prestigious medical journal The Lancet.

IPF is a rare and fatal lung disease affecting more than 200,000 patients in the European Union and USA combined, with a survival rate of only 20% after five years..

In February, the European Commission granted marketing authorization for Esbriet (pirfenidone) for the treatment of adults with mild to moderate IPF (The Pharma Letter March 3). The drug is already marketed in Japan as Pirespa by Shionogi but it has found the US approval pathway more rocky. However, a couple of months ago the Food and Drug Administration's Pulmonary-Allergy Drugs Advisory Committee voted by a narrow nine to three to recommend approval of pirfenidone for the treatment of patients with idiopathic pulmonary fibrosis (IPF) to reduce decline in lung function (TPL March 10).