FDA Issues Guidance on Plasma Fibrinogen as Biomarker in COPD Trials

July 10, 2015

The FDA is adding plasma fibrinogen as a prognostic biomarker for patient selection in clinical trials involving chronic obstructive pulmonary disease and a high risk of death.

In draft guidance issued today, the agency explains how manufacturers can qualify PF through CDER’s Biomarker Qualification Program and avoid having the agency review and reconfirm the tool when they submit investigational and new drug and biologics applications.

Patients selected for clinical trials should have a clinical history of COPD that includes cigarette smoking of 10 pack-years or greater (a pack-year is equal to smoking 20 cigarettes a day for a year) and obstructive lung conditions consistent with an increased risk for exacerbations or all-cause mortality, the FDA says. They should also have a history of COPD exacerbations in the year prior to the trial.

While the guidance focuses mainly on use of PF as a criterion for patient inclusion or exclusion, the biomarker may also be used as an enrichment factor. Sponsors seeking to use it for enrichment should propose an appropriate threshold for baseline PF and discuss it with the agency during the protocol development phase, the FDA says.

The document is meant for use in conjunction with the final guidance, Qualification Process for Drug Development Tools.

Read Qualifications of Biomarker — Plasma Fibrinogen in Studies Examining Exacerbations and/or All-Cause Mortality in Patients with Chronic Obstructive Pulmonary Disease at www.fdanews.com/07-07-15-plasmafibrinogen.pdf. — John Bechtel