2 IPF Drugs Get FDA Approval, Pulmonary Fibrosis Foundation’s Praise

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The Pulmonary Fibrosis Foundation (PFF) applauded the recent news that both Esbriet® (pirfenidone) and Ofev® (nintedanib) were approved by the Food and Drug Administration (FDA) to treat idiopathic pulmonary fibrosis (IPF). These drugs are the first FDA-approved disease-specific therapies for IPF in the US.

The PFF noted in a press release that it is encouraged by the FDA’s move to approve Esbriet and Ofev given the urgent unmet medical needs associated with the disease, noting that one IPF patient in the world dies every 13 minutes, according to the organization. These drugs previously received “fast-track” and “breakthrough therapy” designations by the FDA in order to speed-up the review process.

PFF Chief Medical Officer, Gregory P. Cosgrove, MD, said that this event was a landmark day in the pulmonary fibrosis research and care in the country: “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., Esbriet’s manufacturer, expects that the drug will be available to be prescribed within 2 weeks. The drug has been available in Asia since 2008 and in Europe since 2012. Boehringer-Ingelheim Pharmaceuticals, Inc., OFEV’s distributer, expects it to be available for prescription within 10 days.

Patti Tuomey, PFF President and COO, EdD, noted the importance of IPF patients who made this possible: “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 (…) 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.”

PFF CEO Daniel M. Rose, MD, noted that, while these new drugs offer hope for the IPF patient population, there is still no cure for the disease, and therefore it is important that all patients continue participating in clinical trials to help researchers develop a better understanding of the disease and to develop treatments for it: “advances in the field will only occur through collaboration between patients and the clinicians and scientists so vigorously investigating the disease,” he said.

The PFF remains focused on its mission of advancing basic and clinical PF research so that a cure for the disease can be found. The multi-center PFF Care Center Network and the PFF Patient Registry have been established to drive new projects and to ultimately improve the quality of PF patients. The PFF is available to provide any information about Esbriet and OFEV to the pulmonary fibrosis community (the PFF can be reached at 844.TalkPFF and pcc@pulmonaryfibrosis.org). The organization also offers educational materials, webinars about the disease, and online access to support groups for patients suffering from PF.

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