PFF SUBMITS SURVEY DATA FROM MORE THAN 1,100 PULMONARY FIBROSIS PATIENTS AND FAMILIES TO US FDA FOR UPCOMING DRUG DEVELOPMENT MEETING

Sep 16, 2014, 16:50 PM
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FOR IMMEDIATE RELEASE

Media Inquiries:
Michelle Michael
VP, Marketing & Communications
312-239-6628
mmichael@pulmonaryfibrosis.org

                        

PFF SUBMITS SURVEY DATA FROM MORE THAN 1,100 PULMONARY FIBROSIS PATIENTS AND FAMILIES TO U.S. FOOD AND DRUG ADMINISTRATION FOR UPCOMING DRUG DEVELOPMENT MEETING

•    Survey Data Requested by FDA for the September 26 Patient-Focused Drug Development Meeting for Idiopathic Pulmonary Fibrosis
•    Data to be used to help develop guidelines for pulmonary fibrosis clinical trials


CHICAGO, September 16, 2014/PR Newswire/-- The Pulmonary Fibrosis Foundation (PFF) announced today that it has submitted survey data from more than 1,100 patients and families suffering from pulmonary fibrosis (PF) to the U.S. Food and Drug Administration (FDA) for the Patient-Focused Drug Development Meeting for Idiopathic Pulmonary Fibrosis on September 26. This is a new FDA initiative to seek patient input in order to better understand patients’ needs and expectations for therapeutic treatments.

“We applaud the FDA for focusing its attention on this devastating disease and for recognizing the importance of direct patient participation in this process,” PFF President and COO Patti Tuomey, EdD, said. “We are pleased to be able to play a role and ensure that patients’ voices are heard at this landmark meeting. We wholeheartedly support the FDA’s goal of including patients as an important component in the design and implementation of clinical trials."

To date, more than 1,200 individuals have responded. The survey was developed by the PFF’s medical staff, pulmonary fibrosis thought leaders and former FDA officials.

“Specific questions posed by the FDA were addressed in the PFF Survey, which will provide important feedback to the FDA,” PFF Chief Medical Officer Gregory P. Cosgrove, MD, said. “For example, 25 percent of respondents indicated that they
have seen no improvement in their condition based on their current treatment regimen. Insights such as this will help the FDA better assess quality of life issues when evaluating new therapies.”

The survey also noted that shortness of breath and fatigue were the most severe symptoms (65% and 21%) that patients experienced. Fifty-one percent of patients said that because of their symptoms they cannot participate in regular sporting activities, 47% are unable to dance, 29% cannot garden, 19% cannot travel by airplane, 18% cannot walk up stairs and 13% cannot drive.  

Dr. Cosgrove plans to present the interim survey findings to the FDA during the meeting. These results will also be posted in the public comments section on the FDA website.

While certain survey questions were designed to meet specific objectives of the upcoming FDA meeting, a broader scope of questions were posed that will help the PFF better understand the unique needs of patients and families and will help guide future Foundation programs and initiatives. The survey will be active through the end of the year, and any PF patient or caregiver can participate. To complete this important survey please visit www.adgsurveys.com:8080/f/331806/34fb/.

The FDA’s Patient-Focused Drug Development Meeting for Idiopathic Pulmonary Fibrosis will be held on Friday, September 26 from 1:00-5:00 p.m. EST in Silver Spring, Md. at the FDA’s White Oak Campus, 10903 New Hampshire Avenue, Building 31, Room 1503B/C (Great Room). The meeting will also be webcast. Registration for the meeting or the webcast can be found by visiting www.eventbrite.com/e/public-meeting-on-idiopathic-pulmonary-fibrosis-patient-focused-drug-development-registration-11505211397.

Additionally the PFF will host a webinar on September 17 at noon Central time for anyone interested in learning more about drug development. PFF Senior Medical Advisor David Lederer, MD; PFF Summit 2015 Chair Harold Collard, MD; and PFF Summit 2013 Faculty Member Eugene Sullivan, MD, will present. To register for this PFF webinar and to submit questions for discussion please visit https://attendee.gotowebinar.com/register/2431866093757395201.


About the Pulmonary Fibrosis Foundation National Survey of PF Patients and Families
The national survey of patients and families has been funded by the Pulmonary Fibrosis Foundation and is being administered by Michaels Opinion Research, an independent research firm based in New York, NY. The survey was designed according to the highest standards of independent research practices and is expected to be completed by December, 2014. To complete the survey, please visit http://www.adgsurveys.com:8080/f/331806/34fb/

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 888.733.6741 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. There is presently no 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.


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