FDA Releases Guidance on Developing Drugs for COPD

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The draft guidance helps companies design new treatments of chronic obstructive pulmonary disease.

FDA released draft guidance on May 19, 2016 to assist the industry in designing clinical development programs for treatments of chronic obstructive pulmonary disease (COPD). The guidance emphasizes the assessment of efficacy of a new molecular entity in Phase III clinical studies of COPD.

According to FDA, COPD is a chronic progressive disease caused by chronic inflammation and destruction of the airways and lung parenchyma that is characterized by progressive airflow obstruction. Because of the rise of patients suffering with COPD, FDA states there is a pressing need to develop new treatments.   The guidance states that current COPD medications are symptomatic treatments that do not alter the underlying inflammation or alter disease progression. “With improved understanding of the pathophysiology and clinical manifestations of COPD, and the awareness of the importance of inflammation in COPD and how this inflammation differs from that occurring in asthma, this is an appropriate time to define characteristics of specific drug development programs for COPD,” the guidance states.

The guidance outlines considerations for a development program that include disease target and indication, types of COPD drugs including altering disease progression and modifying lung structure, drug development population, dose selection, assessment of efficacy, number and duration of studies, and demonstrating safety. The guidance also features an appendix:  St. George’s Respiratory Questionnaire In Chronic Obstructive Pulmonary Disease Studies.


The new draft guidance revises the November 2007 guidance, Chronic Obstructive Pulmonary Disease: Developing Drugs for Treatment.

Source: FDA