WASHINGTON, D.C. - May 25, 2016 - The U.S. Food and Drug Administration (FDA) has issued an updated draft guidance for industry to assist in the design of a clinical development programs for new COPD drug and biological products. The draft guidance, “Chronic Obstructive Pulmonary Disease: Developing Drugs for Treatment,” revises the 2007 version by adding information specific to the use of the St. George’s Respiratory Questionnaire (SGRQ) as a potential co-primary endpoint in clinical trials of COPD products. The SGRQ is a patient-reported health status questionnaire that has been used extensively since it was first published over 20 years ago. The COPD Foundation, along with its partners in the COPD Biomarker Qualification Consortium (CBQC) - AstraZeneca, Boehringer-Ingelheim, Chiesi, GSK, Novartis, Pfizer, and many academic members - has long advocated for the broader recognition of the SGRQ as an important endpoint in the development of new drugs to treat COPD since it measures the impact of the disease on health related quality of life from a patient perspective. Paul Jones, Emeritus Professor of Respiratory Medicine at St. George’s University of London, Global Medical Expert at GSK, CBQC member and the author of the SGRQ, said he was especially pleased that the FDA has qualified a patient-reported outcome that measures the impact of COPD from a patient’s perspective.

Since its inception in 2010, the CBQC has selected several important measures, including biomarkers, to be considered for qualification by the FDA as tools for drug development. The initial measures/biomarkers selected were plasma fibrinogen (a blood biomarker), the SGRQ, and the 6-minute walk test (an exercise test). The expanded reference regarding the use of the SGRQ as a valid co-primary endpoint in COPD drug/biologic development, described in the FDA’s updated draft guidance, follows on the successful July 2015 qualification of plasma fibrinogen as a biomarker for use in patient stratification.

“We are encouraged by the FDA’s commitment to update the 2007 draft guidance and include patient-centered outcomes such as the SGRQ. It is a step change in facilitating the development of medicines for COPD that highlights the value of the CBQC’s mission: to integrate data that support regulatory qualification of drug development tools,” said Ruth Tal-Singer, VP Clinical Discovery at GSK and industry chair of the CBQC. "The COPD Foundation and the over 30 million patients with COPD have long-waited for breakthrough therapies that can utilize the SGRQ as a co-primary endpoint in clinical trials,” according to Grace Anne Dorney Koppel, President of the COPD Foundation. “The new draft guidance does that and gives us hope for new and better treatments that take into account the patients’ perception of quality of life in the here and now. Until we have medications that can alter the progression of COPD, this is a real step forward.”

Once finalized, the draft guidance will represent the FDA’s current thinking on the development of drug and biologic products for the treatment for COPD. The FDA encourages public comment on the body of the draft guidance in addition to the SGRQ information added to Appendix A; the deadline for submitting comments is July 19, 2016.

To obtain a copy of the draft guidance, click here.
Learn more about the COPD Biomarker Qualification Consortium (CBQC) here.