The FDA said that plasma fibrinogen can be used as a biomarker in interventional clinical trials examining patients at high risk for exacerbations or all-cause mortality in chronic obstructive pulmonary disease.
The biomarker can be used by drug developers in submissions of INDs, NDAs, and BLAs without the relevant CDER review group reconsidering and reconfirming the suitability of the biomarker, the agency said in final guidance published Sept. 13. A draft version of the guidance was published in July; FDA said it received no public comments.
Fibrinogen, a protein produced by the liver, is a major factor in the formation of blood clots. Measured at baseline, the prognostic biomarker should be considered with other subject demographic and clinical characteristics, including a prior history of COPD exacerbations, as an enrichment factor in these trials, the FDA said.
The use of plasma fibrinogen levels in clinical trials was evaluated by CDER’s Biomarker Qualification Program.
Fibrinogen was qualified using multiple assays, and an optimal enrichment threshold has not been determined, the guidance says. — Conor Hale