AstraZeneca's (AZN.US) and Amgen (AMGN.US) "First-in-class" medicine is recognized as a breakthrough therapy by the FDA for treating COPD.

On August 1, 2023, Amgen (AMGN.US) announced that Tezspire (tezepelumab), a “first-in-class” monoclonal antibody developed by Amgen and AstraZeneca (AZN.US) for the treatment of moderate to severe chronic obstructive pulmonary disease (COPD) in patients with eosinophilic phenotype, was granted breakthrough therapy designation by the FDA as an add-on maintenance therapy for these patients. The two companies are planning to initiate a phase 3 trial in COPD patients.

Tezepelumab is a “first-in-class” human monoclonal antibody targeting thymic stromal lymphopoietin (TSLP), a keratinocyte-derived cytokine that drives excessive immune responses to allergic, eosinophilic, and other forms of airway inflammation. The therapy was approved by the FDA in December 2021 as an add-on maintenance therapy for severe asthma in patients 12 years and older. Tezepelumab is also being developed for other potential indications, including COPD, chronic rhinosinusitis with polyps, chronic spontaneous urticaria, and eosinophilic esophagitis.