FDA issues draft guidance on COPD drug development

The U.S. Food and Drug Administration (FDA) recently added information on using the St. George’s Respiratory Questionnaire (SGRQ) in its newest version of draft guidance in drug development for Chronic Obstructive Pulmonary Disease (COPD).

The last time that the “Chronic Obstructive Pulmonary Disease: Developing Drugs for Treatment” was updated was in 2007, the COPD Foundation noted. The SGRQ would act as a co-primary endpoint for clinical trials for treatment development. The COPD Foundation and the COPD Biomarker Qualification Consortium (CBQC) have advocated its use as a patient-reported health status assessment.

“We are encouraged by the FDA’s commitment to update the 2007 draft guidance and include patient-centered outcomes such as the SGRQ," Industry Chair of the CBQC and VP of Clinical Discovery at GSK Ruth Tal-Singer said. "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.” 

The FDA will be accepting public commentary on the draft guidance and information provided by the SGRQ. Comments will be accepted until July 19.

The CBQC consists of academic institutions and pharmaceutical companies including GSK, AstraZeneca and Pfizer.