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.
- Tezspire works by inhibiting the action of TSLP, a cytokine that is released in response to triggers associated with asthma exacerbations.
- Tezspire is the only biologic approved for severe asthma with no phenotype (e.g. eosinophilic or allergic) or biomarker limitation within its approved label.
- Tezspire is administered via subcutaneous injection once every four weeks.
- Common adverse reactions include pharyngitis, arthralgia, and back pain.
- Tezspire is also in development for other potential indications including chronic obstructive pulmonary disease, chronic rhinosinusitis with nasal polyps, chronic spontaneous urticaria and eosinophilic esophagitis (EoE).
Development timeline for Tezspire
| Date | Article |
|---|
| Feb 2, 2023 | Approval Tezspire Approved for Self-Administration in the U.S. With a New Pre-filled Pen |
| Dec 17, 2021 | Approval FDA Approves Tezspire (tezepelumab) for Severe Asthma |
| Oct 8, 2021 | Tezepelumab Granted Orphan Drug Designation in the US for Eosinophilic Esophagitis |
| Sep 5, 2021 | New Tezepelumab Data Show 86% Reduction In Exacerbations In Patients With Severe Asthma And Comorbid Nasal Polyps |
| Jul 7, 2021 | Tezepelumab Granted Priority Review By U.S. FDA |
| May 13, 2021 | New Tezepelumab Data Continue To Strengthen Profile For A Broad Population Of Severe Asthma Patients |
| May 10, 2021 | Amgen Announces Tezepelumab Biologics License Application Submitted To U.S. FDA |
| Feb 26, 2021 | Tezepelumab is the First Biologic to Consistently and Significantly Reduce Exacerbations in Broad Population of Severe Asthma Patients |
| Dec 21, 2020 | Update On SOURCE Phase 3 Trial For Tezepelumab In Patients With Severe, Oral Corticosteroid-Dependent Asthma |
| Nov 10, 2020 | Tezepelumab 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, 2020 | Tezepelumab 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, 2018 | Tezepelumab Granted Breakthrough Therapy Designation By US FDA For The Treatment Of Patients With Severe Asthma Without An Eosinophilic Phenotype |
| Sep 6, 2017 | Tezepelumab Significantly Reduced Asthma Exacerbations For A Broad Population Of Patients With Severe Uncontrolled Asthma |
Further information
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