CULVER CITY, Calif., Sept. 11, 2014 (GLOBE NEWSWIRE) -- Never before have there been so many opportunities for patients to be heard regarding a deadly lung disease than this month: the U.S. Food and Drug Administration (FDA) is hosting the first FDA workshop on Idiopathic Pulmonary Fibrosis (IPF); groups of patient advocates will canvas Capitol Hill; and patients and family members hold grass roots efforts nationwide to raise awareness. All the while the FDA is reviewing what could be the first two approved therapies for the disease.
Pulmonary Fibrosis (PF) is a lung disease characterized by progressive and irreversible scarring that renders the lungs unable to exchange blood oxygen. Patients die in an average 2.8 years and the disease claims as many lives as breast cancer. When the cause of the disease is unknown, it is referred to as idiopathic.
The Coalition for Pulmonary Fibrosis (CPF), a non-profit group that has organized efforts around PF Awareness every September for 13 years, is working with FDA to make their workshop on September 26th more accessible to IPF patients. The workshop's purpose is for FDA to hear directly from patients about the symptoms that matter most to them and current approaches to treating IPF, according to the FDA.
Since most IPF patients require supplemental oxygen and have difficulty walking due to their reduced lung function, the FDA will be increasing the number of shuttles it normally operates from the FDA parking area to the FDA meeting location at the request of the CPF. The CPF is sponsoring the availability of supplemental oxygen at the FDA meeting so patients can more easily attend the four-hour event. Most IPF patients require higher oxygen levels, and therefore can use significant amounts of oxygen in a short time. Such a meeting would be impossible for many IPF patients to attend without the option of oxygen refills.
"The CPF is pleased to support the FDA as it prepares for direct testimony from the people who suffer from IPF," said Mishka Michon, Chief Executive Officer of the CPF, "We want to make it easier for patients to participate in this hugely important meeting."
To insure patients have ample time to sign up for the FDA IPF Workshop that will also be available to a limited number of people online, the FDA extended the deadline for patients and stakeholders to register to attend online or in person. It moved the deadline from September 10th to September 17th (to register, see below "About the FDA Workshop").
Recently, the U.S. Food and Drug Administration (FDA) granted breakthrough therapy designation for two investigational treatments for the disease: Boehringer Ingelheim's nintedanib and InterMune's pirfenidone. If approved, they will be the first therapies available to patients in the U.S.
National Pulmonary Fibrosis Awareness Month in September
The CPF is sponsoring special campaigns during the 13th annual National Pulmonary Fibrosis Awareness Month – including an effort by its member patients, their family members, and advocates, who are canvassing the nation to increase awareness of the disease with efforts ranging from mayoral and gubernatorial proclamations to meetings in districts and on Capitol Hill with congressional members and their offices. Many CPF members will be holding fundraising and awareness events on a local level, as well. The CPF and the American Thoracic Society (ATS) will co-host a disease awareness week September 21-27 during which they will co-host an IPF patient education event with Johns Hopkins Medical Center at its Bayview Campus, on September 27th. The event will be webcast, as well. To register for the in-person meeting at Johns Hopkins or to join the webinar, email firstname.lastname@example.org. The CPF will bring patients and advocates to Capitol Hill on September 25th and will take a group of its members to the White House on the morning of September 26th before attending the FDA IPF Workshop.
Background on IPF Drugs under FDA Review
Recently, the U.S. Food and Drug Administration (FDA) granted breakthrough therapy designation for two investigational treatments for the disease: Boehringer Ingelheim's nintedanib and InterMune's pirfenidone. In May, both companies reported positive data from their Phase 3 clinical trials at the American Thoracic Society international medical conference.
About the FDA IPF Workshop
The workshop is a public meeting on idiopathic pulmonary fibrosis, as part of FDA's Patient-Focused Drug Development initiative. The purpose of the meeting is to hear patients' perspectives on the symptoms of idiopathic pulmonary fibrosis that matter most to them and on current approaches to treating idiopathic pulmonary fibrosis. This meeting is free and open to the public. Details: Date: Friday, September 26, 2014, Time: 1:00 pm – 5:00 pm, Location: FDA White Oak campus at 10903 New Hampshire Avenue, Silver Spring, MD. Registration is required. Attendees can register online: http://patientfocusedipf.eventbrite.com. Please note that registration ends on September 17, 2014. Remote access will be available via live webcast for those unable to attend in person. Patient representatives, such as caretakers or leaders of support groups, are welcome to attend and share their perspectives. A public docket will also be available, which will give patients (including those not attending the workshop) an opportunity to submit comments to FDA online or through mail. For more information, visit the FDA website:
Report to the FDA
The CPF is currently gathering patient experiences via a software platform survey system with the Genetic Alliance called PEER. The program allows the CPF to query its patients, their family members and caregivers as well as the families of deceased patients, about what they have gone through with the disease. The CPF will analyze the data and present it to the FDA in a report in time for the FDA IPF Workshop. The survey can be found on the CPF's website at: http://www.coalitionforpf.org/peer-portal/
About Pulmonary Fibrosis (PF)
Pulmonary Fibrosis (PF) is a lung disorder characterized by a progressive scarring – known as fibrosis -- and deterioration of the lungs, which slowly robs its victims of their ability to breathe. Approximately 200,000 Americans suffer from PF, and there is currently no known cause or cure. An estimated 48,000 new cases are diagnosed each year. PF is difficult to diagnose and an estimated two-thirds of patients die within five years of diagnosis. Sometimes PF can be linked to a particular cause, such as certain environmental exposures, chemotherapy or radiation therapy, residual infection, or autoimmune diseases such as scleroderma or rheumatoid arthritis. However, in many instances, no known cause can be established. When this is the case, it is called idiopathic pulmonary fibrosis (IPF).
About the CPF
The CPF is a 501C(3) nonprofit organization, founded in 2001 to accelerate research efforts leading to a cure for pulmonary fibrosis (PF), while educating, supporting, and advocating for the community of patients, families, and medical professionals fighting this disease. The CPF funds promising research into new approaches to treat and cure PF; provides patients and families with comprehensive education materials, resources, and hope; serves as a voice for national advocacy of PF issues; and works to improve awareness of PF in the medical community as well as the general public. The CPF's nonprofit partners include many of the most respected medical centers and healthcare organizations in the U.S. With more than 28,000 members nationwide, the CPF is the largest nonprofit organization in the U.S. dedicated to advocating for those with PF. For more information please visit www.coalitionforpf.org or call (888) 222-8541.
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Source:Coalition for Pulmonary Fibrosis(CPF)