FDA Accepts Priority Review Of InterMune’s NDA For Pirfenidone

The FDA has accepted for review and granted priority review designation for the InterMune’s New Drug Application (NDA) for Pirfenidone, for the treatment of patients with idiopathic pulmonary fibrosis (IPF).

The company said that the preclinical and in-vitro evidence had shown that Pirfenidone has both anti-fibrotic and anti-inflammatory effects. Results from three adequate and well-controlled phase 3 studies have shown evidence of a treatment effect in IPF patients and the compound has been safe and generally well tolerated, with the most common side effects including photosensitivity rash and gastrointestinal symptoms.

InterMune has licensed Pirfenidone from Marnac and its co-licensor, KDL in 2002, and in 2007 purchased from Marnac and KDL the rights to sell the compound in the US, Europe and other territories (except in Japan, Taiwan and South Korea where rights to the molecule were licensed by Marnac and KDL to Shionogi of Japan). In October 2008, Pirfenidone was approved for use in IPF patients in Japan and is marketed as Pirespa by Shionogi in that country.

Dan Welch, chairman, president and CEO of InterMune, said: “We are pleased to have begun the review process of the first NDA submitted to FDA for a medicine for IPF patients and we look forward to working with the Pulmonary-Allergy Division to complete the review as expeditiously and thoughtfully as possible.”