▎WuXiEdited by Kant Content Team
Amgen recently stated in its Q2 2024 earnings report that its "first-in-class" monoclonal antibody, developed in collaboration with AstraZeneca,Tezspire (tezepelumab) Receives FDA Breakthrough Therapy Designation as an Add-On Maintenance Treatment for Patients with Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD), these patients have an eosinophilic phenotype. The two companies are planning to initiate a Phase 3 clinical trial in COPD patients.
In China,Tezepelumab is being developed forAsthma, Sinusitis,EsophagitisMultiple clinical studies, the indications under study do not yet include COPD.
This FDA approvaltezepelumabThe Breakthrough Therapy Designation is based on the results of the Phase 2a clinical trial COURSE. Previously released data showed that the drug was able to reduce the incidence of moderate or severe COPD exacerbations. Specific data are as follows:At week 52, treatment with tezepelumab numerically reduced the annual rate of moderate or severe COPD exacerbations by 17% compared to placebo, but the difference was not statistically significant.。However, importantly, this proof-of-concept study shows,In patients with blood eosinophil count (BEC) ≥150 cells/µL, tezepelumab reduced the rate of moderate or severe COPD exacerbations by 37% numerically compared to placebo.Studies show that approximately 65% of COPD patients have a BEC ≥ 150 cells/μL.In patients with BEC≥300 cells/μL, tezepelumab numerically reduced the rate of moderate or severe COPD exacerbations by 46%.Tezepelumab is a “first-in-class” human-derived, targeted anti-thymic stromal lymphopoietin (TSLP) monoclonal antibody.TSLP is an epithelial cytokine located at the top of many inflammatory cascades, capable of triggering excessive immune responses to allergic, eosinophilic, and other types of airway inflammation.TezepelumabIn December 2021, it was approved by the U.S. FDA as an add-on maintenance therapy for treating severe asthma in children aged 12 years and older and adults. In addition to severe asthma, tezepelumab is also being developed for the treatment of other potential indications, including chronic obstructive pulmonary disease, chronic rhinosinusitis with nasal polyps, chronic spontaneous urticaria, and eosinophilic esophagitis.In China, byAstraZeneca's submissiontEzepelumab injection has been approved for four clinical trials, targeting indications including:Treatment of Uncontrolled Severe Asthma in Pediatric Patients Aged 5 Years and Above but Under 12 Years
Add-on maintenance treatment for patients with severe asthma aged 12 years and above
Treatment of eosinophilic esophagitis (EoE) in adolescents aged 12 years and older and adults
Severe Chronic Rhinosinusitis with Nasal Polyps
Source of the image: Screenshot from CDEAccording toInformation from the China Drug Clinical Trial Registration and Information Disclosure Platform shows that currently tEzepelumab for Adult Severe Asthma andTwo studies on severe chronic rhinosinusitis with nasal polyps have completed recruitment, while two other studies are still in the patient recruitment phase.
Image Source:Screenshot of the China Drug Clinical Trial Registration and Information Disclosure Platform
[1] AMGEN REPORTS SECOND QUARTER 2024 FINANCIAL RESULTS. Retrieved August 9, 2024, from https://www.amgen.com/newsroom/press-releases/2024/08/amgen-reports-second-quarter-2024-financial-resultsThis article is from the content team of WuXi AppTec. Individuals are welcome to share it on their social media circles. For authorization to reproduce or other cooperation requests, please contact wuxi_media@wuxiapptec.com.
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