US FDA has given priority review for pulmonary fibrosis drug pirfenidone, Intermune Inc has said in a press announcement.
Pirfenidone is indicated for the treatment of patients with idiopathic pulmonary fibrosis (IPF).
Pirfenidone granted Priority Review designation for the New Drug Application (NDA), InterMune, Inc said.
Priority Review designation may be granted by the FDA to an NDA for drugs that offer major advances in treatment, or provide a treatment where no adequate therapy exists.
Priority Review designation has the potential to expedite the NDA approval process by reducing the target review period for the application from approximately 10 months to six months. Based on the Prescription Drug User Fee Act (PDUFA), the FDA has set an action date for the NDA of May 4, 2010.
Preclinical and in-vitro evidence had shown that pirfenidone has both anti-fibrotic and anti-inflammatory effects.
Results from three Phase 3 studies have shown that pirfenidone treatment is effective in IPF patients.
Pirfenidone has been safe and generally well tolerated, with the most common side effects including photosensitivity rash and gastrointestinal symptoms.
“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,” Dan Welch, chairman, chief executive officer and president of InterMune stated.
InterMune licensed pirfenidone from Marnac, Inc. and its co-licensor, KDL GmbH, in 2002 and in 2007 purchased from Marnac and KDL the rights to sell the compound in the United States, Europe and other territories except in Japan, Taiwan and South Korea where rights to the molecule were licensed by Marnac and KDL to Shionogi & Co. Ltd. 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.
Idiopathic pulmonary fibrosis (IPF) is a disabling and ultimately fatal disease that affects approximately 200,000 patients in the United States and Europe combined, with approximately 30,000 new cases reported per year in each of the United States and Europe.
Idiopathic pulmonary fibrosis is characterized by inflammation and scarring (fibrosis) in the lungs, hindering the ability to process oxygen and causing shortness of breath (dyspnea) and cough and is a progressive disease, meaning that over time, lung scarring and symptoms increase in severity.
The median survival time from diagnosis is two to five years, with a five-year survival rate of approximately 20%. Patients diagnosed with IPF are usually between the ages of 40 and 70, with a median age of 63 years and the disease tends to affect slightly more men than women. There are no medicines approved in the United States or Europe for the treatment of IPF.
InterMune is a biotechnology company focused on the research, development and commercialization of innovative therapies in pulmonology and hepatology.
InterMune has an R&D portfolio addressing idiopathic pulmonary fibrosis (IPF) and hepatitis C virus (HCV) infections. The pulmonology portfolio includes pirfenidone for which InterMune has completed a Phase 3 program in patients with IPF (CAPACITY) and a New Drug Application (NDA) currently is being reviewed by the FDA.
InterMune’s hepatology portfolio includes the HCV protease inhibitor compound RG7227 (ITMN-191) that entered Phase 2b in August 2009 and a second-generation HCV protease inhibitor research program.