CPF Applauds Two FDA Approvals Announced Today for First Drugs for Idiopathic Pulmonary Fibrosis

FDA Approves Esbriet and Ofev on Same Day


CULVER CITY, CALIF., Oct. 15, 2014 (GLOBE NEWSWIRE) -- The Coalition for Pulmonary Fibrosis (CPF) applauds the two U.S. Food and Drug Administration (FDA) approvals announced today for Idiopathic Pulmonary Fibrosis (IPF), the first drugs approved for the disease in the United States.

The CPF, representing tens of thousands of Idiopathic Pulmonary Fibrosis (IPF) patients is sharing the news with the patient and research community that FDA approved InterMune's Esbrriet (pirfenidone) and Boehringer Ingelheim's Ofev (nintedanib) for Idiopathic Pulmonary Fibrosis (IPF).

"It is a historic for IPF patients with two first-ever treatments for IPF being approved by the FDA," said Mishka Michon, CEO of the CPF. "With these therapies comes hope for a brighter future for patients and renewed optimism regarding the battle against IPF amongst physicians and researchers."

The drugs are the first FDA approved therapies for the disease that affects 200,000 Americans and claims as many lives each year as breast cancer. IPF is a lethal lung disease that is irreversible, progressive and deadly in an average of three years.

Earlier this year, both Boehringer Ingelheim and InterMune announced positive results from their Phase 3 drug trials that demonstrated reduction in disease progression. Both drugs were given breakthrough designation by the FDA. The agency first reviewed InterMune's drug in 2010 and asked for further study of pirfenidone after an FDA Advisory Committee recommended approval of the drug.

Pulmonary Fibrosis is a disease that causes scarring in the lungs and renders them unable to exchange life sustaining blood oxygen. When the cause cannot be determined, it is called idiopathic. The disease strikes randomly, putting everyone at risk, and the causes of PF are largely unknown. The seriousness of PF along with the size of the patient community has drawn increased attention from researchers and pharmaceutical companies.

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). Partnering with the American Thoracic Society, the CPF has supported IPF research efforts, funding more than $1.2 Million to date.

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 200,000 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.  

•    The Coalition for Pulmonary Fibrosis (CPF) is the preeminent patient and physician resource for Pulmonary Fibrosis.  [www.coalitionforpf.org, 888-222-8541]


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.

A photo accompanying this release is available at:
http://www.globenewswire.com/newsroom/prs/?pkgid=28383

CONTACT:Teresa Barnes
         303-521-4080
         tbarnes@coalitionforpf.org
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