First COPD Biomarker Approved By FDA

First COPD Biomarker Approved By FDA

The COPD Foundation has announced that plasma fibrinogen, a new clinical biomarker, was approved to be used in interventional clinical trials for those suffering with chronic obstructive pulmonary disease (COPD), the number 3 cause of death in the country. This is the first biomarker for COPD to receive qualification from the United States Food and Drug Administration (FDA) and is the conclusion of 6 years of hard work and commitment by the COPD Biomarker Qualification Consortium (CBQC).

COPD causes difficult and long-term disabilities. Over 24 million Americans suffer from the disease and 50 percent remain undiagnosed. One American dies every 4 minutes because of COPD; however, in the last 3o years, only a single novel class of drug has received approval to address COPD.

The CBQC, integrates resources and representatives from both university and government research, patient communities and pharmaceutical and it was formed in 2010 by the COPD Foundation; it was encouraged by the FDA and the National Heart, Lung and Blood Institute, to advance a “biomarker qualification process” for the disease. Biomarkers are used bt researchers as a measure of a disease severity and to assess if a new treatment or drug is being effective. If a biomarker qualified by the FDA can be used to assess a drug’s efficacy by drug developers, it will lead to a more streamlined approval process.

“This is a major triumph and, on behalf of the entire COPD community, I extend a heart-felt thank you to the FDA and congratulate the CBQC on its commitment and tireless leadership that allowed us to reach this significant milestone. Individuals working in the pharmaceutical industry, universities and the patient community have spent several million dollars and countless hours assembling and analyzing data that has led to the FDA’s monumental decision to approve this first COPD biomarker. Ultimately this clinical biomarker will enable future drug development to benefit patients,” noted John W. Walsh, who is the president and co-founder of the COPD Foundation.

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