FDA Approves Esbriet (pirfenidone) for Idiopathic Pulmonary Fibrosis

Pirfenidone is a drug developed by several companies worldwide, including InterMune Inc. (now part of Roche), Shionogi Ltd., and GNI Group Ltd., for the treatment of idiopathic pulmonary fibrosis (IPF). In 2008, it was first approved in Japan for the treatment of IPF after clinical trials, under the trade name of Pirespa by Shionogi & Co. In October 2010, the Indian Company Cipla launched it as Pirfenex. In 2011, it was approved for use in Europe for IPF under the trade name Esbriet.  was approved in Canada in 2012 under the trade name Esbriet; and was approved in the United States in October 2014 under the same name. In September 2011, the Chinese State Food and Drug Administration provided GNI Group Ltd with new drug approval of pirfenidone in China,^[3] and later manufacture approval in 2013 under the trade name of Etuary. 

In continuation of my update on pirfenidone

FDA Approves Esbriet (pirfenidone) for Idiopathic Pulmonary Fibrosis

Researchers identify drugs to slow progression of idiopathic pulmonary fibrosis

Researchers in separate clinical trials found two drugs slow the progression of idiopathic pulmonary fibrosis, a fatal lung disease with no effective treatment or cure, and for which there is currently no therapy approved by the Food and Drug Administration.

Paul W. Noble, MD, chair of the Department of Medicine at Cedars-Sinai and director of the Women's Guild Lung Institute, is the senior author of the multicenter study that found that the investigational drug pirfenidone significantly slowed the loss of lung function and reduced the risk of death. Pirfenidone was developed by InterMune Inc. and in 2011 was approved by the European Union for the treatment of idiopa Studies Published In New England Journal Of Medicine Identify Promising Drug Therapies For Fatal Lung Disease thic pulmonary fibrosis.

The findings of the ASCEND drug trial are published online by the New England Journal of Medicine and are being presented this week at the International Conference of the American Thoracic Society in San Diego. "What we discovered about the anti-inflammatory and anti-fibrotic properties of pirfenidone offers help and encouragement to so many patients suffering from this relentless disease that robs them of breath and life," said Noble.

Researchers identify drugs to slow progression of idiopathic pulmonary fibrosis