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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.  


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SOURCE Coalition for Pulmonary Fibrosis
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