FDA's call for further review of pirfenidone disappointing for Pulmonary Fibrosis patients, says CPF

Coalition for Pulmonary FibrosisMay 5 2010

Decision Marks Delay in Potential First Treatment for Deadly Disease

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):

• 40,000 people will die from PF this year, the same number that is claimed by breast cancer.
• Very few Americans have heard of Pulmonary Fibrosis (PF), but the deadly lung disease characterized by progressive and massive scarring in the lungs affects 128,000 Americans and there are no proven causes and no cure.  
• The average life expectancy from diagnosis to death is just three years.  About 48,000 people will be diagnosed this year.  
• PF Prevalence is increasing – 156% in the past seven years.  The need has never been greater for increased awareness, education, advocacy and research.
• The Coalition for Pulmonary Fibrosis (CPF) is the preeminent patient and physician resource for Pulmonary Fibrosis.  [www.coalitionforpf.org, 888-222-8541]

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.