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Today (November 22), the official website of the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) announced,AstraZeneca and Amgen jointly submittedTezepelumab InjectionThe listing application has been accepted. Public information shows that this isMonoclonal antibody targeting thymic stromal lymphopoietin (TSLP): Tezepelumab (Tezspire). This therapy was approved by the U.S. FDA in December 2021 as an additional maintenance therapy,For the treatment of severe asthma in children aged 12 years and older and adults. Clarivate, a well-known institution in the industry, oncePoint out, this therapy is expected to become a "blockbuster" new drug by 2026.Based on the registration classification applied for, it is speculated that the indication for which this product is being submitted for marketing approval in China this time may beFor the treatment of severe asthma in children aged 12 years and older and adults. At the same time, the pipeline information on AstraZeneca's official website also pointed out,The first indication for which the drug will be filed in the Chinese market is for the treatment of severe asthma.。
Screenshot source:CDE Official WebsiteTSLP 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. FDAApprovalAs an additional maintenance therapy,TreatmentFor the treatment of severe asthma in children aged 12 years and older and adults。In September 2018, the FDA granted tezepelumab Breakthrough Therapy Designation for the treatment of patients with severe asthma without an eosinophilic phenotype. Its Biologics License Application (BLA) also received Priority Review designation from the FDA. In clinical practice, this product only requires subcutaneous injection once every four weeks.
This FDA approval is based on the clinical development program named PATHFINDER, including the results of the pivotal Phase 3 clinical trial NAVIGATOR. The results of the NAVIGATOR trial were published in The New England Journal of Medicine in May 2021. The trial results showed that tezepelumab achieved all primary endpoints and key secondary endpoints in treating patients with severe asthma whose symptoms were uncontrolled.Reduced the annual asthma exacerbation rate (AAER) by 56% compared to placebo。 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. The product was alsoGranted Breakthrough Therapy Designation by the FDA as an add-on maintenance treatment for patients with moderate to very severe chronic obstructive pulmonary disease (COPD).。According toInformation from the China Drug Clinical Trial Registration and Information Disclosure Platform shows that currently tEzepelumab targetsPhase 3 clinical study for adult severe asthma has been completed, and the study for treating uncontrolled severe asthma in children aged 5 years and older but under 12 is currently recruiting.
Image Source:Screenshot of the China Drug Clinical Trial Registration and Information Disclosure Platform[1] Center for Drug Evaluation, National Medical Products Administration of ChinaNet. Retrieved Nov 22, 2024, from https://www.cde.org.cn/main/xxgk/listpage/da6efd086c099b7fc949121166f0130c[2] TEZSPIRE (tezepelumab) Approved in the US for Severe Asthma. Retrieved December 18, 2021, from https://www.businesswire.com/news/home/20211217005407/en
[3] AstraZeneca Official Website. From https://www.astrazeneca.com/our-therapy-areas/pipeline.html
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