Regulatory Focus™ > News Articles > FDA Offers New Guidance on Qualified Biomarker for COPD Trials

FDA Offers New Guidance on Qualified Biomarker for COPD Trials

Posted 14 September 2016 | By Zachary Brennan 

FDA Offers New Guidance on Qualified Biomarker for COPD Trials

The US Food and Drug Administration (FDA) on Wednesday issued guidance providing a qualified context of use (COU) for the biomarker plasma fibrinogen in interventional clinical trials of patients with chronic obstructive pulmonary disease (COPD) at high risk for exacerbations and/or all-cause mortality.

This guidance describes the experimental conditions and constraints for which this biomarker is qualified through the CDER Biomarker Qualification Program, and can be used for the qualified COU in submissions of investigational new drug applications (INDs), new drug applications (NDAs) and biologics license applications (BLAs) without the relevant CDER review group reconsidering and reconfirming the suitability of the biomarker.

FDA says fibrinogen was qualified primarily based on GlaxoSmithKline’s Evaluation of COPD Longitudinally to Identify Predictive Surrogate End-points (ECLIPSE) study data that used an immunological assay that measured a range of fibrinogen concentrations between 100-900 milligrams/deciliter.


The plasma fibrinogen level of patients selected for clinical trials should be determined at baseline, FDA says, noting that it can be used as an enrichment factor, in addition to standard inclusion/exclusion criteria, in COPD clinical trials with endpoints of COPD exacerbation and/or all-cause mortality.

In terms of patient selection, FDA says they should have a clinical history of COPD as defined by the American Thoracic Society/European Respiratory Society (ATS/ERS) standards prior to enrollment in the trial, which involves a history of cigarette smoking 10 pack-years or greater and obstructive lung physiology consistent with an increased risk for exacerbations and/or all-cause mortality. Patients enrolled in COPD exacerbation trials should also have a history of COPD exacerbations in the year prior to enrollment, the agency noted.

“Because fibrinogen was qualified using multiple assays, an optimal enrichment threshold has not been determined. Therefore, a drug sponsor should propose an appropriate threshold for a baseline plasma fibrinogen level and discuss it with FDA during the protocol development phase,” FDA adds.

FDA Guidance for Industry: Qualification of Biomarker Plasma Fibrinogen in Studies Examining Exacerbations and/or All-Cause Mortality in Patients With Chronic Obstructive Pulmonary Disease

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