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AstraZeneca recently announced that the US FDA has granted Tezepelumab orphan drug certification for the treatment of a rare inflammatory disease, eosinophilic esophagitis (EoE)
EoE is a rare chronic inflammatory disease involving a series of inflammatory cells, which can cause severe pain and dysphagia in patients
Tezepelumab was jointly developed by AstraZeneca and Amgen.
As early as July of this year, the US FDA has accepted the application for a biological product license (BLA) for the antibody drug tezepelumab for the treatment of severe asthma and granted priority review
Tezepelumab BLA is based on positive data from the PATHFINDER clinical program, including positive results from the pivotal Phase 3 NAVIGATOR trial
The NAVIGATOR trial is the first phase III trial that shows the therapeutic benefit of targeting TSLP for severe asthma
In addition, in the subgroup of patients with a baseline eosinophil count of <300 cells/μl, the trial also reached the primary endpoint: compared with placebo+SoC, tezepelumab+SoC treatment made AAER statistically significant and Decrease of clinical significance
According to estimates by AstraZeneca and Amgen, the US FDA is expected to make a decision on the priority review of Tezepelumab for American asthma patients in the first quarter of 2022
At the same time, Tezepelumab is also undergoing regulatory review of asthma in the European Union and Japan
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