WASHINGTON--(EON: Enhanced Online News)--The COPD Biomarkers Qualification Consortium (CBQC) announced today at the European Respiratory Society Annual Congress that it has submitted a Qualification Package to the Food and Drug Administration (FDA) for plasma fibrinogen as a new drug development tool. The Qualification Package is the result of progressive discussions between the FDA’s Qualification Review Team and the CBQC.
“The Consortium is providing a unique and productive opportunity to bring new drug development tools to the research community, with the ultimate goal of providing new treatments to patients who urgently need them.”
“To the best of CBQC’s knowledge, fibrinogen is the first clinical biomarker achieving this milestone in the U.S.,” says Dr. Ruth Tal-Singer, CBQC co-chair, vice president, Clinical Discovery, Respiratory Area Therapy Unit at GlaxoSmithKline. “This breakthrough highlights the power of working together across multiple companies, academic centers and government organizations to achieve our common objective of improving the way we study novel medicines. The CBQC looks forward to the results of FDA review while planning for a fall 2013 submission to the European Medicines Agency.”
To support the Fibrinogen package, CBQC compiled a unique database of subjects from five individual studies, allowing integrated analyses to support two proposed uses as a prognostic biomarker to enrich clinical trial populations with Chronic Obstructive Pulmonary Disease (COPD) subjects at increased risk for all-cause mortality or COPD exacerbations.
Fibrinogen, a protein that can be measured in the blood, is a promising biomarker -- a tool used for early detection of a disease – that identifies a group representing 25 to 30 percent of all COPD patients.
Dr. Stephen Rennard, CBQC co-chair and Larson Professor of Medicine, University of Nebraska, states, “The heterogeneous nature of COPD complicates development of new treatments, with COPD patients responding differently. Fibrinogen has been submitted to the FDA as a tool that will help address this problem.”
John W. Walsh, president and co-founder, COPD Foundation, adds, “The Consortium is providing a unique and productive opportunity to bring new drug development tools to the research community, with the ultimate goal of providing new treatments to patients who urgently need them.”
About the COPD Foundation
The mission of the COPD Foundation (www.COPDFoundation.org) is to develop and support programs, which improve the quality of life through research, education, early diagnosis, and enhanced therapy for persons whose lives are impacted by chronic obstructive pulmonary disease.