The clinical biomarker plasma fibrinogen has been granted approval for use in interventional clinical tests, which makes it the first COPD biomarker to receive FDA approval, according to a COPD Foundation announcement.
The FDA decision culminates 6 years of work from the COPD Biomarker Qualification Consortium (CBQC). A Lung Disease News report notes the use of an FDA-approved biomarker allows pharmaceutical companies to conduct more sound clinical tests as findings are less likely to be based on participant selection or the process by which the drug was measured.
The CBQC was first founded by the COPD Foundation in 2010 after being urged by the US FDA and the National Heart, Lung and Blood Institute to work on establishing a COPD-tailored “biomarker qualification process,” according to Lung Disease News.
John Walsh, co-founder and president of the COPD Foundation, says, “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.”
Walsh adds, “Individuals working in the pharmaceutical industry, universities and the patient community have spent several million dollars and countless hours assembling and analyzing 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.”
Source: Lung Disease News