Tezspire approved for self-administration in the US with a new pre-filled pen

Tezspire approved for self-administration in the US with a new pre-filled pen

First and only respiratory biologic without phenotype or biomarker limitations that offers the choice of administration at home or in a doctor’s office

AstraZeneca and Amgen’s Tezspire (tezepelumab) has been approved in the US for self-administration in a pre-filled, single-use pen for patients aged 12 years and older with severe asthma. Tezspire is the only biologic approved for severe asthma with no phenotype (e.g. eosinophilic or allergic) or biomarker limitation within its approved label.¹

The approval by the US Food and Drug Administration (FDA) was based on results from the PATHFINDER clinical trial programme, which included results from the PATH-BRIDGE Phase I trial and the PATH-HOME Phase III trial.2,3 The majority (92%) of healthcare providers, patients and caregivers were able to successfully administer Tezspire  both in the clinic and at home throughout the PATH-HOME trial.3 The improvements in asthma control and the safety profile of Tezspire observed in the PATH-HOME trial were consistent with previous clinical trials.3

Kenneth Mendez, President and CEO of the Asthma and Allergy Foundation of America, said: “Severe asthma continues to be a very complex condition to manage, so we welcome the Tezspire pre-filled pen as an option that will empower patients and healthcare providers with increased choice. We believe self-administration alternatives can play an important role in patients’ lives and address unmet needs for those living with severe asthma.”

References

1. Tezspire US prescribing information. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761224s000lbl.pdf. [Last accessed: January 2023].

2. Zheng Y, et al. Tezepelumab Pharmacokinetics, Safety, and Tolerability After Administration via Vial-and-syringe, Accessorized Prefilled Syringe, or Autoinjector: A Randomized Trial in Healthy Volunteers. Clin Thera. 2020;43(1):142-155.

3. Alpizar S, et al. Functionality and Performance of an Accessorized Pre-Filled Syringe and an Autoinjector for At-Home Administration of Tezepelumab in Patients with Severe, Uncontrolled Asthma. J. Asthma Allergy. 2021;14:381-392.

4. AstraZeneca plc. Tezspire (tezepelumab) approved in the US for severe asthma. Available at: https://www.astrazeneca.com/media-centre/press-releases/2021/Tezspire-tezepelumab-approved-in-the-us-for-severe-asthma.html. [Last accessed: January 2023].

5. AstraZeneca plc. Tezspire approved in the EU for the treatment of severe asthma. 2022. Available at: https://www.astrazeneca.com/content/astraz/media-centre/press-releases/2022/tezspire-approved-in-the-eu-for-the-treatment-of-severe-asthma.html. [Last accessed: January 2023].

6.  AstraZeneca plc. Tezspire approved in Japan for the treatment of severe asthma. Available at: https://www.astrazeneca.com/media-centre/press-releases/2022/tezspire-approved-in-japan-for-severe-asthma.html. [Last accessed: January 2023].

7. Menzies-Gow A, et al. Tezepelumab in Adults and Adolescents with Severe, Uncontrolled Asthma. N Engl J Med. 2021;384: 1800-1809. DOI: 10.1056/NEJMoa2034975.

8. Corren J, et al. Tezepelumab in adults with uncontrolled asthma [supplementary appendix; updated April 18, 2019]. N Engl J Med. 2017;377:936-946.

9. Varricchi G, et al. Thymic Stromal Lymphopoietin Isoforms, Inflammatory Disorders, and Cancer. Front Immunol. 2018;9:1595.

10. Li Y, et al. Elevated Expression of IL-33 and TSLP in the Airways of Human Asthmatics In Vivo: A Potential Biomarker of Severe Refractory Disease. J Immunol. 2018;200:2253-2262.

Ruud Dobber, Executive Vice President and President, BioPharmaceuticals Business Unit, AstraZeneca, said: “Tezspire is the first and only biologic approved for patients with severe asthma with no phenotype or biomarker limitation within its approved label. With the approval of the pre-filled pen in the US, we can now offer greater flexibility to patients and physicians with the option to administer Tezspire at home or in the clinic.”

Tezspire  self-administration and the Tezspire  pre-filled pen are also approved in the European Union (EU) and are under regulatory review in several other countries around the world. Tezspire is currently approved for the treatment of severe asthma in the US, EU, Japan and other countries.4-6