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Esbriet

Generic name: pirfenidone
Treatment for: Idiopathic Pulmonary Fibrosis

Update: Esbriet (pirfenidone) Now FDA Approved - October 15, 2014

Coalition for Pulmonary Fibrosis Responds to News of Further Review of Pirfenidone By FDA

SAN JOSE, Calif., May 4 /PRNewswire-USNewswire/ -- The Coalition for Pulmonary Fibrosis (CPF), representing tens of thousands of patients, is responding to the news that the FDA chose to ask for further study of Pirfenidone, which will delay potential approval of the first drug in the treatment of Pulmonary Fibrosis (PF), a lethal lung disease that is irreversible, progressive and deadly in an average of three years. On March 9, 2010, an FDA Advisory Committee recommended approval of the drug by the FDA.

"This news is disappointing for the Pulmonary Fibrosis patient community," said Mishka Michon, CEO of the CPF. "Although the drug is not seen as a cure, it offers the first-ever option for treatment and some hope for these dying patients. This is a setback for those patients who are anxious to gain access to this treatment now. We look forward to results of further review of the drug by the FDA. We are hopeful that more attention to the disease will come and much will be learned that will encourage even more companies to research PF. The need is profound and urgent."

Pulmonary Fibrosis is a disease that causes scarring in the lungs and renders them unable to exchange life sustaining blood oxygen. The disease strikes randomly, putting everyone at risk, and the causes of PF are largely unknown.

Important Facts about Pulmonary Fibrosis (PF)

The CPF has long advocated on behalf of researchers and patients for accelerated research efforts to treat and cure PF, both in terms of drug development efforts by the pharmaceutical industry and research funded by the National Institutes of Health (NIH). With more than 23,000 members nationwide, the CPF is the largest nonprofit organization in the U.S. dedicated to advocating for those with PF.

The CPF is available to help members of the media with background information on PF, to provide comment on the delay of the drug and to provide interviews with CPF leaders and with patients affected by the disease. Additional information and background on the CPF and the disease is available on the CPF website at www.coalitionforpf.org. The CPF funds research primarily through a partnership with the American Thoracic Society, and has directly funded emerging research at several of the nation's leading centers for the treatment of PF including the University of Chicago, University of Michigan, and the David Geffen School of Medicine at UCLA.

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 128,000 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 501©(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 23,000 members nationwide, the CPF is the largest nonprofit organization in the U.S. dedicated to advocating for those with PF.

Posted: May 2010

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