To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: Pirfenidone Approved in Japan for Treatment of Idiopathic Pulmonary Fibrosis URL: http://www.pslgroup.com/dg/22EECA.htm Doctor's Guide October 16, 2008
NEW YORK -- October 16, 2008 -- The Japanese Ministry of Health, Labor and Welfare (MHLW) has approved pirfenidone for the treatment of patients with idiopathic pulmonary fibrosis (IPF) in Japan. The approval is based on the results of 2 randomised, double-blind, placebo-controlled, phase 3 studies. The Clinical Studies Assessing Pirfenidone in IPF: Research of Efficacy and Safety Outcomes (CAPACITY) trials included 779 patients with IPF at 110 centres in the US, Europe, and Australia. The primary endpoint in CAPACITY was change in Forced Vital Capacity (FVC) from baseline to week 72. InterMune states that 97% of transplant-free, surviving patients had completed the week 72 visit and primary endpoint was being assessed. The CAPACITY protocol calls for a final patient visit to be completed 30 days after the week 72 visit. All patient visits for CAPACITY are expected to be completed around the end of October 2008. Based on this timeline for study completion, InterMune expects to announce efficacy and safety results in January or February of 2009. SOURCE: InterMune --------------------------------------------------------------------------------------------- Copyright © 1999 P\S\L Consulting Group Inc. All rights reserved. Republication or redistribution of P\S\L content is expressly prohibited without the prior written consent of P\S\L. P\S\L shall not be liable for any errors, omissions or delays in this content or any other content on its sites, newsletters or other publications, nor for any decisions or actions taken in reliance on such content. --------------------------------------------------------------------------------------------- This news story was printed from *Doctor's Guide to the Internet* located at http://www.docguide.com --------------------------------------------------------------------------------------- Return to News Story Page This site is maintained by webmaster@pslgroup.com Please contact us with any comments, problems or bugs. All contents Copyright (c) 1998 P\S\L Consulting Group Inc. All rights reserved.