Friday, May 16, 2014

Expanded Access Program: You might be able to get pirfenidone in the U.S. soon...

Intermune announced an Expanded Access Program for pirfenidone for people with Idiopathic Pulmonary Fibrosis. Below is a press release from the Pulmonary Fibrosis Foundation. For more information, contact the PFF's Patient Communication Center at 844.TalkPFF (844.825.5733) or email PCC@pulmonaryfibrosis.org.

(Full disclosure: I sat on Intermune's Steering Committee for the ASCEND trial of pirfenidone for IPF and I've received consulting funds from Intermune for the past few years.)

Here's the press release:

PULMONARY FIBROSIS FOUNDATION PROVIDES THE LATEST DISEASE EDUCATION INFORMATION
Now includes information about InterMune’s Expanded Access Program

CHICAGO, May, 16 2014/PR Newswire/-- The newly launched Pulmonary Fibrosis Foundation Patient Communication Center (PCC) has become the destination for the most up-to-date information for the pulmonary fibrosis community. The PCC now has information about the Expanded Access Program (EAP) for pirfenidone.

“The Pulmonary Fibrosis Foundation (PFF) is committed to serve as an impartial resource for the PF community,” said Patti Tuomey, EdD, President and Chief Operating Officer. “The PFF is enthusiastic about the changing landscape of available treatments for this devastating and fatal disease. We are pleased to be able to share all the latest information with the community.”

Today, InterMune, Inc. announced that the company will provide compassionate use of pirfenidone through a multi-center Expanded Access Program (EAP) in the United States. There are a limited number of participating sites accepting patients at this time, but it is expected that all clinical sites will be ready to accept patients by the end of September.
 
“Patients and caregivers have been waiting for the development of new IPF treatments. An Expanded Access Program allows patients to actively participate in the search for therapies that may positively impact their health,” said Gregory Cosgrove, MD, Chief Medical Officer for the Pulmonary Fibrosis Foundation. “The PFF welcomes all medical news concerning the development of potential treatments and is committed to sharing these updates with the PF community.” Dr. Cosgrove is Associate Professor of Medicine in the Pulmonary Division at National Jewish Health in Denver, CO.

Please call 844.TalkPFF (844.825.5733) or email PCC@pulmonaryfibrosis.org to learn more about InterMune’s EAP program and how to find out about sites that are accepting patients.

For more information on the Pulmonary Fibrosis Foundation or to get involved, please visit www.pulmonaryfibrosis.org.

3 comments :

  1. Coalition for PF also has this http://www.coalitionforpf.org/2014/05/16/idiopathic-pulmonary-fibrosis-pati ents-to-have-expanded-access-to-therapy/ with a link to Q&A http://www.coalitionforpf.org/wp-content/uploads/2014/05/QA-with-Dr-Leff-CP F-5-15-14-FINAL.pdf which is an Interview with Jonathan A. Leff, M.D., InterMune’s Executive Vice President of Research and Development.

    PFF forum also provided this link for information on EAP in general http://www.fda.gov/ForConsumers/ByAudience/ForPatientAdvocates/AccesstoInve stigationalDrugs/ucm176098.htm

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