Esbriet (Pirfenidone) Passes Hurdle, Way Clear for EU Approval
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, Esbriet (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 Esbriet.
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