COPD consortium seeks qualification of fibrinogen as biomarker

The Chronic Obstructive Pulmonary Disease Biomarkers Qualification Consortium (CBQC) submitted a biomarker qualification package to FDA for plasma fibrinogen. The consortium said the submission is the first for clinical biomarker qualification in the U.S. The package includes data from five studies and supports the uses of plasma fibrinogen as a prognostic biomarker to enrich trials with COPD patients at increased risk for all-cause mortality or COPD exacerbations. The consortium said if FDA qualifies fibrinogen as a biomarker, companies "could choose to use it along with other factors" in patient selection for trials. There is no defined timeline for an FDA decision. CBQC plans to submit a data package for the biomarker to EMA in the fall. The not-for-profit COPD Foundation launched the consortium, which includes government agencies, academic institutions and pharmas, in 2010. ...