The FDA has approved the first COPD biomarker for use in interventional clinical trials.
The blood biomarker plasma fibrinogen can now be used in studies that examine exacerbations and/or all-cause mortality in patients with COPD, the regulatory body said in a statement.
The initial biomarkers selected were plasma fibrinogen, St. George’s Respiratory Questionnaire, and the 6-minute walk test.
“We applaud the FDA for approving plasma fibrinogen as a biomarker and hope to develop a clear path forward on the SGRQ and the 6-minute walk test biomarkers as well,” said the COPD Foundation’s Biomarker Qualification Consortium.