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Tezspire FDA Approval History

Last updated by Judith Stewart, BPharm on Dec 20, 2021.

FDA Approved: Yes (First approved December 17, 2021)
Brand name: Tezspire
Generic name: tezepelumab-ekko
Dosage form: Injection
Company: Amgen and AstraZeneca
Treatment for: Asthma

Tezspire (tezepelumab-ekko) is a thymic stromal lymphopoietin (TSLP) blocker, human monoclonal antibody (IgG2λ), indicated for the add-on maintenance treatment of adult and pediatric patients aged 12 years and older with severe asthma.

Development timeline for Tezspire

Feb  2, 2023Approval Tezspire Approved for Self-Administration in the U.S. With a New Pre-filled Pen
Dec 17, 2021Approval FDA Approves Tezspire (tezepelumab) for Severe Asthma
Oct  8, 2021Tezepelumab Granted Orphan Drug Designation in the US for Eosinophilic Esophagitis
Sep  5, 2021New Tezepelumab Data Show 86% Reduction In Exacerbations In Patients With Severe Asthma And Comorbid Nasal Polyps
Jul  7, 2021Tezepelumab Granted Priority Review By U.S. FDA
May 13, 2021New Tezepelumab Data Continue To Strengthen Profile For A Broad Population Of Severe Asthma Patients
May 10, 2021Amgen Announces Tezepelumab Biologics License Application Submitted To U.S. FDA
Feb 26, 2021Tezepelumab is the First Biologic to Consistently and Significantly Reduce Exacerbations in Broad Population of Severe Asthma Patients
Dec 21, 2020Update On SOURCE Phase 3 Trial For Tezepelumab In Patients With Severe, Oral Corticosteroid-Dependent Asthma
Nov 10, 2020Tezepelumab NAVIGATOR Phase III Trial Met Primary Endpoint of a Statistically Significant and Clinically Meaningful Reduction in Exacerbations in a Broad Population of Patients with Severe Asthma
Nov  9, 2020Tezepelumab NAVIGATOR Phase 3 Trial Met Primary Endpoint Of A Statistically Significant And Clinically Meaningful Reduction In Exacerbations In A Broad Population Of Patients With Severe Asthma
Sep  6, 2018Tezepelumab Granted Breakthrough Therapy Designation By US FDA For The Treatment Of Patients With Severe Asthma Without An Eosinophilic Phenotype
Sep  6, 2017Tezepelumab Significantly Reduced Asthma Exacerbations For A Broad Population Of Patients With Severe Uncontrolled Asthma

Further information

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