**Repost** “Today is a landmark day in the history of pulmonary fibrosis research and care in the United States,” PFF Chief Medical Officer Gregory P. Cosgrove, MD said. “These FDA approvals give patients renewed hope that their condition can be managed more effectively and that decades of research into this largely unknown disease are beginning to uncover a new understanding of how to slow IPF’s unrelenting progression.” Please read our press release in its entirety below. PULMONARY FIBROSIS FOUNDATION APPLAUDS THE FOOD AND DRUG ADMINISTRATION’S (FDA) PROMPT DECISION TO APPROVE ESBRIET® (PIRFENIDONE) AND OFEV® (NINTEDANIB) FOR THE TREATMENT OF IDIOPATHIC PULMONARY FIBROSIS First FDA Approved Treatments in United States for Devastating Lung Disease Affecting More than 200,000 Americans, with Survival Rate of Just Three to Five Years CHICAGO, October 16, 2014/PR Newswire/ -- The Pulmonary Fibrosis Foundation (PFF) applauds the approval of Esbriet® (pirfenidone) and OFEV® (nintedanib) by the U.S. Food and Drug Administration (FDA) as the first disease-specific therapies for idiopathic pulmonary fibrosis (IPF) in the United States. Yesterday, the FDA approved Esbriet and OFEV for the treatment of idiopathic pulmonary fibrosis, both of which had previously received “Fast-Track” and “Breakthrough Therapy” designations by the FDA to further accelerate the review process. With one IPF patient dying every 13 minutes in the United States, the PFF is pleased to see the FDA complete its review process so promptly following these important regulatory designations. “Today is a landmark day in the history of pulmonary fibrosis research and care in the United States,” PFF Chief Medical Officer Gregory P. Cosgrove, MD said. “These FDA approvals give patients renewed hope that their condition can be managed more effectively and that decades of research into this largely unknown disease are beginning to uncover a new understanding of how to slow IPF’s unrelenting progression.” InterMune, Inc., the manufacturer of Esbriet, expects the drug to be available by prescription within two weeks. The drug has been available in Asia since 2008 and in Europe since 2012. Boehringer-Ingelheim Pharmaceuticals, Inc. distributes OFEV and expects it to be available by prescription within ten days. “The PFF also recognizes the incredible contribution of thousands of patients who made the important decision to participate in each stage of clinical trials, many of whom have since passed away,” commented PFF President and COO Patti Tuomey, EdD. “Their commitment is a source of inspiration to all patients and families who have suffered from this disease, and their participation means that so many current and future patients will now have new treatment choices.” “Until a cure is found, we hope that all patients will continue to participate in clinical trials to help researchers develop a better understanding of, and treatments for, pulmonary fibrosis – it’s the best pathway to eventually identifying a cure,” noted PFF CEO Daniel M. Rose, MD. “Advances in the field will only occur through collaboration between patients and the clinicians and scientists so vigorously investigating the disease.” The PFF stands ready to provide information about Esbriet and OFEV to the PF community through the PFF Patient Communication Center (844.TalkPFF and [email protected]). The PFF is aggressively pursuing its mission to advance basic and clinical PF research to ultimately find a cure. To this end, the PFF has established the multi-center PFF Care Center Network and the PFF Patient Registry to drive new research and improve the quality of care for people with PF. The PFF also offers educational materials, disease education webinars, and access to online and in-person PF support groups for those affected by PF.
Posted on: Fri, 17 Oct 2014 01:05:00 +0000
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