Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 22 |
| INN | Tezepelumab |
| Status | Approved |
| Drug code(s) | AMG 157, MEDI-9929 |
| Brand name | Tezspire |
| mAb sequence source | mAb human |
| General Molecular Category | Naked monospecific |
| Format, general category | Full length Ab |
| Format details | None |
| Isotype (Fc) | IgG2 |
| Light chain isotype | lambda |
| Linker | None |
| Ave. DAR | None |
| Conjugated/fused moiety | None |
| Discovery method/technology | Transgenic mouse (Xenomouse) |
| Target(s) | TSLP |
| Indications of clinical studies | Chronic Rhinosinusitis With Nasal Polyps, COPD, asthma, cat allergy, Atopic Dermatitis |
| Primary therapeutic area | Immune-mediated / inflammatory disorders |
| Most advanced stage of development (global) | Approved EU, US, Japan |
| Status | Active |
| Start of clinical phase (IND filing or first Phase 1) | August 08, 2008 |
| Start of Phase 2 | December 13, 2013 |
| Start of Phase 3 | November 23, 2017 |
| Date BLA/NDA submitted to FDA | May 07, 2021 |
| Year of first approval (global) | 2021 |
| Date of first US approval | December 17, 2021 |
| INN, US product name | Tezepelumab, tezepelumab-ekko |
| US or EU approved indications | Add-on maintenance treatment of adult and pediatric patients aged 12 years and older with severe asthma |
| Company | Amgen |
| Licensee/Partner | AstraZeneca |
| Comments about company or candidate | July 7, 2021: Amgen announced that the U.S. Food and Drug Administration (FDA) has accepted a Biologics License Application (BLA) and granted Priority Review for tezepelumab in the treatment of asthma. PDUFA action date is during the first quarter of 2022. May 10, 2021: announced its partner AstraZeneca submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for tezepelumab, a potential first-in-class medicine in severe asthma. The submission is supported by positive clinical trial results from the PATHFINDER clinical program including the pivotal NAVIGATOR Phase 3 trial, which demonstrated a statistically significant and clinically meaningful reduction in the annualized asthma exacerbation rate (AAER) in patients with severe, uncontrolled asthma compared to placebo. NCT04851964 Phase 3 in Chronic Rhinosinusitis With Nasal Polyps due to start in April 2021. NCT04039113 Phase 2 in COPD not yet recruiting as of July 31, 2019. NCT03968978 Phase 3 started in May 2019. NCT03927157 Phase 3 study in asthma started recruiting June 14, 2019. AstraZeneca and its partner Amgen announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for tezepelumab in patients with severe asthma, without an eosinophilic phenotype, who are receiving inhaled corticosteroids/long-acting beta2-agonists with or without oral corticosteroids and additional asthma controllers. The Breakthrough Therapy Designation is based on the tezepelumab Phase IIb PATHWAY data that showed a significant reduction in the annual asthma exacerbation rate compared with placebo in a broad population of severe asthma patients irrespective of patient phenotype including Type 2 (T2) biomarker status. NCT03347279 Study to Evaluate Tezepelumab in Adults & Adolescents With Severe Uncontrolled Asthma (NAVIGATOR). NCT02054130 Phase 2 study completed in March 2017 IND filed Aug 8, 2008 [https://www.accessdata.fda.gov/drugsatfda_docs/nda/2022/761224Orig1s000MultidisciplineR.pdf] |
| Full address of company | Thousand Oaks, California, United States North America United States of America https://www.amgen.com/ |
None
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |