Chronic Obstructive Pulmonary Disease (COPD) is a progressive disorder associated with chronic inflammation of the airways and lungs. Persistent breathing difficulties and repeated exacerbations of COPD symptoms make the disease one of the leading causes of morbidity and the fifth-leading cause of death in the world. COPD is linked to cumulative exposure to risk factors, primarily tobacco smoke, but also environmental pollutants. The COPD marketed products landscape consists of pharmacological therapies aimed at managing the symptoms associated with COPD, although none of the available therapies have been shown to modify long-term disease progression.
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The current COPD pipeline consists of 212 active products in development. Initial analysis revealed a small presence of first-in-class products, constituting 16.5% of the pipeline. In comparison to other indications, this is relatively low; however, there are some promising trends within COPD product development. The Preclinical Phase of development is the most active in terms of first-in-class products. This diminishes throughout clinical development, with only two such products being present in Phase III. However, if either of these products is approved, they would represent the first, first-in-class products to be approved for COPD since roflumilast, which was approved in 2011 by the FDA and in 2010 in the EU. Roflumilast was the first novel therapy for COPD in almost 20 years, which demonstrates the infrequency at which first-in-class products enter the COPD market. So to have two first-in-class products in Phase III and six in Phase II is a promising sign.
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