The COPD Foundation, a 501(c)(3) not-for-profit organization created in 2004 to undertake initiatives that result in expanded services for COPD and improve the lives of individuals affected by COPD, announced that a new clinical biomarker, plasma fibrinogen, has been approved for use in interventional clinical trials in patients with chronic obstructive pulmonary disease, the nation’s 3rd leading cause of death. This is the first COPD biomarker to receive qualification by the US Food and Drug Administration (FDA) and is the result of six years of work by the COPD Biomarker Qualification Consortium (CBQC).
The CBQC, which includes representatives and resources from university and government research, pharmaceutical and patient communities, was created by the COPD Foundation in 2010, with encouragement from the FDA and the National Heart, Lung and Blood Institute, to develop a “biomarker qualification process” for COPD.
Biomarkers are medical processes that researchers use to measure disease severity or to determine if a new drug or treatment is effective. Being able to use a biomarker qualified by the FDA assures drug developers that any potential new drug applications will not be rejected simply because of how the drug’s efficacy was measured or how patients were selected.
“This is a major triumph and, on behalf of the entire COPD community, I extend a heart-felt thank you to the FDA and congratulate the CBQC on its commitment and tireless leadership that allowed us to reach this significant milestone,” said John W. Walsh, co-founder and president of the COPD Foundation.
“Individuals working in the pharmaceutical industry, universities and the patient community have spent several million dollars and countless hours assembling and analysing data that has led to the FDA’s monumental decision to approve this first COPD biomarker. Ultimately this clinical biomarker will enable future drug development to benefit patients.”
COPD causes serious long-term disability and as many as 24 million Americans have the disease, but approximately half of them remain undiagnosed. On average, one American dies from COPD every 4 minutes yet in the last 3 decades, only one new class of drug has been approved for COPD.