Navigation Links
CPF Responds to Positive News on First Drug for Treatment for Pulmonary Fibrosis
Date:12/21/2010

CULVER CITY, Calif., Dec. 21, 2010 /PRNewswire-USNewswire/ -- The Coalition for Pulmonary Fibrosis (CPF) announced to more than 128,000 patients news that the first drug for the treatment of the deadly lung disease Pulmonary Fibrosis (PF) has passed a major hurdle in the European regulatory process and is likely to be approved in all 27 member countries of the European Union (EU).

The drug, Espriet (Pirfenidone), has received a positive opinion by the Committee for Medicinal Products for Human Use (CHMP) of the Europeans Medicines Agency (EMA).  The committee recommends the granting of a marketing authorization for the drug in adults for the treatment of mild to moderate idiopathic pulmonary fibrosis (IPF), a lethal lung disease characterized by progressive scarring of lung tissue.  The committee's positive opinion will now be forwarded to the European Commission for ratification.  The ratification process typically takes two to three months following the adoption of the CHMP opinion.  

"While this likely EU approval does not mean approval here in the U.S., it does mean that patients will have options in making their treatment decisions," said Mishka Michon, Chief Executive Officer of the CPF.

Esbriet has failed to reach regulatory approval in the U.S and was turned down by the Food & Drug Administration (FDA) earlier this year despite a recommendation by an FDA committee recommending approval of the drug.  

The positive news could mean the first approved therapy to treat PF in the western half of the world.  The drug is already approved in Japan and a generic version has been approved in India.  

PF – a relentlessly progressive and ultimately fatal lung disease affects more than 128,000 people and claims 40,000 lives each year.

The CPF recognizes the decision in the EU could impact the review of the drug in the U.S. as the FDA makes its final decisions on Espriet.  

The CPF which has long advocated on behalf of researchers and patients for accelerated research to treat and cure PF, both by the pharmaceutical industry and research funded by the National Institutes of Health (NIH).  The CPF has also directly funded emerging research at several of the nation's leading centers for the treatment and study of PF including The University of Chicago, University of Michigan, and the David Geffen School of Medicine at UCLA and directed more than $600,000 in combined research funding since 2006 through its partnership with the American Thoracic Society (ATS). Complete details on CPF activities, including research, are available on our web page at:  http://www.coalitionforpf.org/cpf_accomplishments.php.

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(c)(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. For more information please visit www.coalitionforpf.org or call (888) 222-8541.


'/>"/>
SOURCE Coalition for Pulmonary Fibrosis
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Marken Rapidly Responds to Global Supply Chain Security Measures
2. PhRMA CEO John Castellani Responds to Mid-Term Election, Stresses Importance of Innovation to Help Grow Economy
3. FRCs Jeanne Monahan Responds to Two New Deaths from RU-486
4. Takeda Responds to Announcement about Suspension of Rosiglitazone Marketing Authorization in Europe and Restrictions in the U.S.
5. Atrium Responds to Bard Suit
6. NVHR Responds to New York Times Article on Hepatitis C Testing
7. Takeda Responds to FDA Advisory Committee Recommendation
8. Coalition for Pulmonary Fibrosis Responds to News of Further Review of Pirfenidone By FDA
9. New Science Education Program Responds to Presidents Call to Help Young People Excel in Science
10. GlaxoSmithKline Responds to US Senate Committee on Finance Report on Avandia
11. U.S. Kidney Dialysis Community Responds to Haitis Emergency Plea for Life-Saving Dialysis Care
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/8/2017)... , June 8, 2017   Responding to Heath ... and the death of singer Chris Cornell in ... Rights International offers a free online psychiatric ... consumers and families about psychotropic drug risks. ... who died from an accidental overdose, has called for tighter ...
(Date:6/7/2017)... Md. , June 7, 2017  Novavax, Inc., (Nasdaq: ... second of two Phase 2 trials of its RSV F ... of child bearing age have been published in the journal ... publication have been shared in prior scientific conferences). The Company ... in April 2014. Novavax is developing the RSV F Vaccine ...
(Date:6/5/2017)... , June 5, 2017 Kohll,s Pharmacy ... the United States . The Raizer is ... a fallen person up to an almost-standing position ... and operated by one assistant and does not ... is simple enough that a child can operate it, ...
Breaking Medicine Technology:
(Date:6/27/2017)... ... June 27, 2017 , ... The Kelahan Agency, a ... to residents of southern New Hampshire, is teaming up with the New Horizons ... and homelessness in the region. , New Horizons for New Hampshire provides a ...
(Date:6/27/2017)... ... , ... Dr. Richard Amato, a respected periodontist in Monroe, CT, ... Implant Center of Connecticut. As part of the renovation, the cutting-edge practice added two ... to improve patient comfort while making it possible for Dr. Amato to provide even ...
(Date:6/27/2017)... ... 2017 , ... East Los Angeles dentist, Ramin Assili DDS , comments ... happens to a woman during pregnancy can have profound effects on a developing fetus, ... on a baby’s long-term health. This study, which was performed at the University of ...
(Date:6/26/2017)... California (PRWEB) , ... June 26, 2017 , ... ... of Male Fertility & Sexual Medicine Specialists, in collaboration with the Fertility Center ... for male fertility care: PESA (percutaneous epidydimal sperm aspiration) and TESA (percutaneous testicular ...
(Date:6/26/2017)... ... , ... LARKR™ , an innovative new smartphone app providing on-demand talk ... to join its online treatment platform. , Launching in just a few days, ... number of people in need nationwide, and to supplement their traditional practices. Joining this ...
Breaking Medicine News(10 mins):