FOR IMMEDIATE RELEASE
Contact:
PFF Patient Communication Center
844.TalkPFF (844.825.5733)
[email protected]
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. 1
“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.
About the Pulmonary Fibrosis Foundation The mission of the Pulmonary Fibrosis Foundation (PFF) is to serve as the trusted resource for the pulmonary fibrosis (PF) community by raising awareness, providing disease education, and funding research. The PFF collaborates with physicians, organizations, patients, and caregivers worldwide. The Pulmonary Fibrosis Foundation has a four-‐star rating from Charity Navigator and is a Better Business Bureau accredited charity. PFF Summit 2015: From Bench to Bedside, the PFF’s third biennial international health care conference, will be held November 12-‐14, 2015 in Washington, DC. For more information visit www.pulmonaryfibrosis.org or call 844.TalkPFF (844.825.5733) or +1 312.587.9272 from outside of the US.
About Idiopathic Pulmonary Fibrosis Idiopathic pulmonary fibrosis (IPF) is a condition in which over a period of time the lung tissue becomes thickened, stiff, and scarred. The development of the scar tissue is called fibrosis. As the lung tissue becomes scarred and thicker, the lungs lose their ability to transfer oxygen into the bloodstream. As a result, the brain and other organs don’t receive the oxygen they need. In some cases, doctors can determine the cause of the fibrosis, but in most cases, there is not a known cause. When there is no known etiology for the fibrosis (and certain pathologic or radiographic criteria are met), the disease is called idiopathic pulmonary fibrosis or IPF. IPF affects between 132,000-‐200,000 people in the United States (US), and between 37,000-‐40,000 people in the European Union (EU). The annual mortality is estimated to be 40,000 in the US, with an average survival of 2–3 years following diagnosis. There is no cure for IPF. Presently, there is one FDA approved treatment for IPF in the US and limited therapeutic options available for individuals with mild-‐to-‐moderate IPF in the EU, Canada, and Asia.
# # # 2