The COPD Foundation, a Washington D.C.- and Florida-based not-for-profit organization dedicated to supporting those living with this debilitating respiratory illness, has just announced that a novel clinical biomarker, plasma fibrinogen, has been granted approval for use in interventional clinical tests, making it the first COPD biomarker to receive approval from the US Food and Drug Administration. This culminates 6 years of work from the COPD Biomarker Qualification Consortium (CBQC).
The CBQC was first founded by the COPD Foundation in 2010 after being urged by the US FDA and the National Heart, Lung and Blood Institute to work on establishing a COPD-tailored “biomarker qualification process.” This refers to processes that scientists can use to assess disease progression or treatment effectiveness. Utilizing an FDA-approved biomarker allows pharmaceutical companies to conduct more sound clinical tests, as their findings are less likely to be based on participant selection or the process by which the drug was measured.
“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,” said John W. Walsh, co-founder and president of the COPD Foundation. “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.”
COPD is a life-long, oftentimes fatal respiratory condition that affects as many as 24 million Americans today. Half of these are not even aware they already have the disease. It is estimated that for every 4 minutes, one American dies from COPD, making it the 3rd leading cause of death in the country. Despite these alarming numbers, over the past 3 decades, only one new class of treatment has achieved US FDA approval.
To learn more about the CBQC, visit http://copdf.co/CBQC-Biomarker.
In a previous report on COPD, following the US Food and Drug Administration‘s final approval of Boehringer Ingelheim Pharmaceuticals, Inc.‘s STIOLTO™ RESPIMAT® (tiotropium bromide and olodaterol) Inhalation Spray in May 2015, the company recently announced that patients with chronic obstructive pulmonary disease (COPD) can now benefit from the novel spray through a doctor’s prescription in all pharmacies nationwide.
STIOLTO RESPIMAT is FDA-approved as a long-term, once-daily maintenance treatment for COPD, and should not be used by patients with asthma or acute deterioration of COPD. It is currently the only inhaler that can effectively deliver a slow-moving mist of medication without requiring inspiratory effort from the patient.