Tezepelumab Explained

Type:mab
Mab Type:mab
Source:u
Target:thymic stromal lymphopoietin (TSLP)
Tradename:Tezspire
Dailymedid:Tezepelumab
Routes Of Administration:Subcutaneous
Atc Prefix:R03
Atc Suffix:DX11
Legal Ca:Rx-only
Legal Ca Comment:/Schedule D[1] [2] [3]
Legal Us:Rx-only
Legal Us Comment:[4]
Legal Eu:Rx-only
Cas Number:1572943-04-4
Drugbank:DB15090
Chemspiderid:None
Unii:RJ1IW3B4QX
Kegg:D11771
Synonyms:MEDI9929, AMG 157, tezepelumab-ekko
C:6400
H:9844
N:1732
O:1992
S:52

Tezepelumab, sold under the brand name Tezspire, is a human monoclonal antibody used for the treatment of asthma.[5] [6] Tezepelumab blocks thymic stromal lymphopoietin (TSLP), an epithelial cytokine that has been suggested to be critical in the initiation and persistence of airway inflammation.[7]

The most common side effects include arthralgia (joint pain) and pharyngitis (sore throat).

Tezepelumab was approved for medical use in the United States in December 2021,[8] [9] and in the European Union in September 2022.[10] The US Food and Drug Administration (FDA) considers it to be a first-in-class medication.[11]

Medical uses

Tezepelumab is indicated for the add-on maintenance treatment of people aged twelve years and older with severe asthma.

History

Two main studies including over 1,500 adults and adolescents with inadequately controlled asthma showed that tezepelumab was effective in reducing the number of severe asthma flare‑ups.

The benefits and side effects of tezepelumab were evaluated in two clinical trials of participants with severe asthma. All participants were taking their usual treatment for asthma. In addition, participants received new treatment with either tezepelumab or placebo. Neither the participants nor the investigators knew which treatment was given. The benefit of tezepelumab was assessed by measuring the frequency of asthma attacks (exacerbations) at the end of both 52 week trials in comparison to placebo.

The FDA approved tezepelumab based on evidence from two clinical trials (NAVIGATOR and PATHWAY) of 1334 participants with severe asthma. The safety and efficacy of tezepelumab were evaluated in two clinical trials of participants with severe asthma. The trials were conducted in 24 countries (Argentina, Australia, Austria, Bulgaria, Brazil, Canada, Czech Republic, France, Germany, Hungary, Israel, Japan, Lithuania, Latvia, Russia, Saudi Arabia, Serbia, Slovakia, South Africa, South Korea, Taiwan, Ukraine, United States, and Vietnam).

Society and culture

Legal status

On 21 July 2022, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Tezspire, intended as add-on treatment in adults and adolescents with severe asthma. The applicant for this medicinal product is AstraZeneca AB.[12] Tezepelumab was approved for medical use in the European Union in September 2022.[13] [14]

Research

It is being studied for the treatment of chronic obstructive pulmonary disease, chronic rhinosinusitis with nasal polyps, chronic spontaneous urticaria and eosinophilic esophagitis (EoE).

In phase III trials, tezepelumab demonstrated efficacy compared to placebo for patients with severe, uncontrolled asthma.[15] [16]

Structural studies by X-ray crystallography showed that tezepelumab competes against a critical part of the TSLPR binding site on TSLP.

Notes and References

  1. Web site: Tezspire Product information . . 25 April 2012 . 1 October 2022 . 1 October 2022 . https://web.archive.org/web/20221001060300/https://health-products.canada.ca/dpd-bdpp/info.do?lang=en&code=101878 . live .
  2. Web site: Summary Basis of Decision - Tezspire . . 23 October 2014 . 24 January 2023 . 24 January 2023 . https://web.archive.org/web/20230124031903/https://hpr-rps.hres.ca/reg-content/summary-basis-decision-detailTwo.php?linkID=SBD00613&lang=en . live .
  3. Web site: Details for: Tezspire . . 19 October 2022 . 3 March 2024.
  4. Web site: Tezspire- tezepelumab-ekko injection, solution . DailyMed . 24 December 2021 . 25 December 2021 . https://web.archive.org/web/20211225032358/https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=60f0aa03-ad25-4d48-80ce-7fcfa76f325f . live .
  5. Marone G, Spadaro G, Braile M, Poto R, Criscuolo G, Pahima H, Loffredo S, Levi-Schaffer F, Varricchi G . 6 . Tezepelumab: a novel biological therapy for the treatment of severe uncontrolled asthma . Expert Opinion on Investigational Drugs . 28 . 11 . 931–940 . November 2019 . 31549891 . 10.1080/13543784.2019.1672657 . 202746054 .
  6. Matera MG, Rogliani P, Calzetta L, Cazzola M . TSLP Inhibitors for Asthma: Current Status and Future Prospects . Drugs . 80. 5. February 2020 . 449–458 . 32078149 . 10.1007/s40265-020-01273-4 . 211194472 .
  7. Tezepelumab granted Breakthrough Therapy Designation by US FDA . AstraZeneca . 7 September 2018 . 10 September 2018 . 10 September 2018 . https://web.archive.org/web/20180910094518/https://www.astrazeneca.com/media-centre/press-releases/2018/tezepelumab-granted-breakthrough-therapy-designation-by-us-fda-07092018.html#! . live .
  8. Web site: Drug Trials Snapshots: Tezspire . U.S. Food and Drug Administration (FDA) . 17 December 2021 . 28 July 2023 . 28 July 2023 . https://web.archive.org/web/20230728202414/https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots-tezspire . live .
  9. Tezspire (tezepelumab) approved in the US for severe asthma . AstraZeneca . 17 December 2021 . 17 December 2021 . 18 December 2021 . https://web.archive.org/web/20211218065930/https://www.astrazeneca.com/media-centre/press-releases/2021/tezspire-tezepelumab-approved-in-the-us-for-severe-asthma.html . live .
  10. Tezspire approved in the EU for the treatment of severe asthma . AstraZeneca . 21 September 2022 . 21 September 2022 . 22 September 2022 . https://web.archive.org/web/20220922032320/https://www.astrazeneca.com/media-centre/press-releases/2022/tezspire-approved-in-the-eu-for-the-treatment-of-severe-asthma.html . live .
  11. Advancing Health Through Innovation: New Drug Therapy Approvals 2021 . U.S. Food and Drug Administration (FDA) . 13 May 2022 . PDF . 22 January 2023 . 6 December 2022 . https://web.archive.org/web/20221206210020/https://www.fda.gov/media/155227/download . live .
  12. Web site: Tezspire: Pending EC decision . European Medicines Agency . 21 July 2022 . 30 July 2022 . 28 July 2022 . https://web.archive.org/web/20220728180616/https://www.ema.europa.eu/en/medicines/human/summaries-opinion/tezspire . live . Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  13. Web site: Tezspire EPAR . European Medicines Agency . 19 July 2022 . 21 September 2022 . 22 September 2022 . https://web.archive.org/web/20220922032609/https://www.ema.europa.eu/en/medicines/human/EPAR/tezspire . live . Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  14. Web site: Tezspire Product information . Union Register of medicinal products . 12 December 2022 . 3 March 2023 . 27 October 2022 . https://web.archive.org/web/20221027221238/https://ec.europa.eu/health/documents/community-register/html/h1677.htm . live .
  15. Web site: Studies found for: Tezepelumab . ClinicalTrials.Gov . National Library of Medicine, National Institutes of Health, U.S. Department of Health and Human Services . 14 March 2020 . 30 July 2022 . https://web.archive.org/web/20220730050825/https://www.clinicaltrials.gov/ct2/results?cond=&term=Tezepelumab . live .
  16. Menzies-Gow A, Corren J, Bourdin A, Chupp G, Israel E, Wechsler ME, Brightling CE, Griffiths JM, Hellqvist Å, Bowen K, Kaur P, Almqvist G, Ponnarambil S, Colice G . 6 . Tezepelumab in Adults and Adolescents with Severe, Uncontrolled Asthma . May 2021 . New England Journal of Medicine . 384 . 19 . 1800–09 . 10.1056/NEJMoa2034975 . 33979488 . 234484931 . free . doi .

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