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Prescribing Information Tezspire®▼(tezepelumab)
Adverse Event Reporting
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Rise above the complexity with TEZSPIRE® (tezepelumab)
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Rise above the complexity with TEZSPIRE® (tezepelumab)1-3,6

 

See full indication

 

TEZSPIRE significantly reduces exacerbations in a broad population of severe uncontrolled asthma patients aged 12 and over3-5*

Navigator
 
Annualised asthma
exacerbation relative risk
reduction
vs placebo

TEZSPIRE 0.93 (n=528) vs placebo 2.1 (n=531) 
RR=0.44, 95% CI: 0.37-0.53;
 P<0.001;

ARR=1.17

 

PRIMARY ENDPOINT OF NAVIGATOR (PHASE III STUDY): AAER VS PLACEBO OVER 52 WEEKS†3,4

 

 

Primary endpoint also assessed in patients with
baseline bEOS <300 cells/μL

SEE EFFICACY DATA
Pathway
 
Annualised asthma
exacerbation relative risk
reduction
vs placebo

TEZSPIRE 0.2 (n=137) vs placebo 0.72 (n=138),
90% CI: 0.54-0.82; P<0.001;

ARR=0.52

 

PRIMARY ENDPOINT OF PATHWAY (PHASE IIb STUDY): AAER VS PLACEBO OVER 52 WEEKS‡4,7

 

SEE EFFICACY DATA

*Patients enrolled with no minimum biomarker requirement (blood EOS, IgE, or FENO).1
†NAVIGATOR study. All patients received SOC (MD or HD ICS + additional controller).3,4
‡PATHWAY study. All patients received SOC (MD or HD ICS + additional controller).4,7

TEZSPIRE treats across phenotypes and irrespective of key clinical biomarker levels1

No restrictions across eosinophilic and non-eosinophilic, allergic and non-allergic phenotypes; eosinophils, IgE, and FeNO biomarkers.

FeNO=fractional exhaled nitric oxide; IgE=immunoglobin E; MOA=mode of action.

EXPLORE MOA

TEZSPIRE (tezepelumab) is indicated as an add-on maintenance treatment in adults and adolescents 12 years and older with severe asthma who are inadequately controlled despite high dose inhaled corticosteroids plus another medicinal product for maintenance treatment1

AAER=annualised asthma exacerbation rate; ARR=absolute risk reduction; CI=confidence interval; bEOS=blood eosinophils; FeNO=fractional exhaled nitric oxide; HD=high dose; ICS=inhaled corticosteroid; IgE=immunoglobulin E; MD=medium dose; MOA=mode of action; RR=rate ratio; SOC=standard of care.

 

  1. Tezspire (tezepelumab). Summary of Product Characteristics. 2022. Available at: https://www.medicines.org.uk/emc/product/14064/smpc (last accessed: November 2024).
  2. Menzies-Gow A, Wechsler ME, Brightling CE. Unmet need in severe, uncontrolled asthma: can anti-TSLP therapy with tezepelumab provide a valuable new treatment option?. Respir Res. 2020;21(1):268.
  3. Menzies-Gow A, Corren J, Bourdin A, et al. Tezepelumab in adults and adolescents with severe, uncontrolled asthma. N Engl J Med. 2021;384(19):1800-1809.
  4. Menzies-Gow A, Corren J, Bourdin A, et al. Supplementary Appendix. Tezepelumab in adults and adolescents with severe, uncontrolled asthma. N Engl J Med. 2021;384(19):1800-1809.
  5. Corren J, Parnes JR, Wang L, et al. Tezepelumab in adults with uncontrolled asthma. N Engl J Med. 2017;377(10):936-946.
  6. Gauvreau GM, Sehmi R, Ambrose CS, Griffiths JM. Thymic stromal lymphopoietin: its role and potential as a therapeutic target in asthma. Expert Opin Ther Targets. 2020;24(8):777-792.
  7. Corren J, Parnes JR, Wang L, et al. Supplementary Appendix. Tezepelumab in Adults with Uncontrolled Asthma N Engl J Med. 2017;377(10):936-946.

GB-62660 | December 2024

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