TEZSPIRE▼(tezepelumab) AUTHORISED IN GREAT BRITAIN FOR THE TREATMENT OF SEVERE UNCONTROLLED ASTHMA

• First and only biologic authorised in Great Britain for patients with severe uncontrolled asthma with no phenotype or key clinical biomarker limitations.^[1]
• The decision is based on data from the pivotal NAVIGATOR Phase III trial which showed that Tezspire (tezepelumab) significantly reduced exacerbations in adults and adolescents with severe, uncontrolled asthma compared to placebo. [2]
• Severe uncontrolled asthma can be debilitating, and patients may not respond well to conventional therapies, leading to exacerbations and a poor quality of life.^[3],[4]

London, UK, 26 September 2022 – AstraZeneca today announced that the Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorisation for Tezspire (tezepelumab) in Great Britain as an add-on maintenance therapy in adult and adolescent patients 12 years and older with severe uncontrolled asthma who are inadequately controlled with high dose inhaled corticosteroids plus another medicinal product for maintenance treatment.¹

This decision is based on data from the PATHFINDER clinical trial programme, which includes positive results from the NAVIGATOR Phase III trial. The NAVIGATOR trial met its primary endpoint in demonstrating that patients with severe uncontrolled asthma who were treated with tezepelumab (n=528) demonstrated a significantly reduced annualised rate of asthma exacerbations (reduction, 56%; rate ratio [RR], 0.44; 95% CI, 0.37 to 0.53; P<0.001), when compared to those treated with placebo (n=531). The trial also met a key secondary endpoint, with patients treated with tezepelumab demonstrating improved lung function (difference in prebronchodilator FEV₁ at 52 weeks, 0.13 litres; 95% CI, 0.08 to 0.18; P<0.001) compared to patients treated with placebo. In an additional secondary endpoint, a reduction of asthma exacerbations associated with hospitalisation was observed in patients treated with tezepelumab (reduction, 79%; RR, 0.21; 95% CI, 0.12 to 0.37), when compared to placebo.²

Tezepelumab is the first-in-class authorised biologic in Great Britain that acts at the top of the inflammatory cascade by blocking thymic stromal lymphopoietin (TSLP), an epithelial cytokine.² It is the first and only authorised biologic to significantly reduce asthma exacerbations versus placebo across the PATHWAY and NAVIGATOR clinical trials, which included a broad population of severe uncontrolled asthma patients irrespective of key biomarkers, including blood eosinophil counts, allergic status and fractional exhaled nitric oxide (FeNO).^2,[5]

Professor Andrew Menzies-Gow, Director of the Lung Division, Royal Brompton Hospital, London, UK, and principal investigator of the NAVIGATOR trial said: “Today’s decision from the MHRA is an important moment for patients living with severe uncontrolled asthma in Great Britain. The NAVIGATOR trial enrolled a broad set of patients, irrespective of phenotype or key clinical biomarker levels, and for the first time has shown the effectiveness of targeting TSLP in severe uncontrolled asthma. As a clinician, I am excited about this novel treatment option that has potential to improve outcomes for eligible people living with severe uncontrolled asthma.”

Around 8 million people, or over 12% of the population, are living with asthma in the UK.^[6] Every 10 seconds someone in the UK has a potentially life-threatening asthma attack, and on average, three people die from asthma every day.^[7] An estimated 200,000 people are living with severe asthma in the UK – this can be a debilitating form of the disease that may not respond well to conventional treatments, leaving these patients more at risk of asthma attacks and asthma-related hospitalisation.³

Results from the NAVIGATOR Phase III trial, published in the New England Journal of Medicine, showed that the study met its primary endpoint, with a reduced annualised rate of asthma exacerbations in patients with severe uncontrolled asthma versus placebo, including patients with baseline blood eosinophil counts of <300 cells per microlitre.²

Ed Piper, Medical & Scientific Affairs Director, AstraZeneca UK, said: “We are thrilled that the MHRA has authorised tezepelumab, a first-in-class biologic therapy that targets the top of the inflammatory cascade. Today’s milestone supports AstraZeneca’s overall ambition to reduce the risk of respiratory attacks in the UK through the use of effective, biologic treatments. We are working with NICE, the SMC, and NHS England to ensure eligible patients have access to tezepelumab as quickly as possible.”

As part of the PATHFINDER programme the adverse event profile was studied across both the tezepelumab and placebo groups.²

In the NAVIGATOR Phase III trial, 528 patients received tezepelumab and 531 received placebo, and the most common adverse reactions that occurred in ≥3% of patients who received tezepelumab included: Nasopharyngitis (21.4%), upper respiratory tract infection (11.2%), headache (8.1%), asthma (5.1%), bronchitis (4.7%), bronchitis bacterial (4.5%), urinary tract infection (4.2%), hypertension (4.4%), back pain (4.0%), arthralgia (3.8%), influenza-like illness (3.6%), sinusitis (3.6%), pharyngitis (3.2%), gastroenteritis (3.2%), viral upper respiratory tract infection (3.2%), and rhinitis allergic (3.0%).^[8]

AstraZeneca is committed to improving asthma care for patients in the UK. We advocate the appropriate use of effective biologic therapies that address the underlying inflammation in severe uncontrolled asthma. We are working towards a zero-tolerance approach to asthma attacks in the UK and are committed to reducing asthma-related exacerbations in a sustainable way that benefits both the patient community and the environment alike.

[1] Electronic Medicines Compendium (EMC). Tezspire 210 mg solution for injection in pre-filled syringe – Summary of Product Characteristics (SmPC). Available at: https://www.medicines.org.uk/emc/product/14064 Last accessed September 2022.

[2] Menzies-Gow A, et al. Tezepelumab in Adults and Adolescents with Severe, Uncontrolled Asthma. N Engl J Med. 2021;384:1800-1809.

[3] Asthma UK. What is severe asthma? Available at: https://www.asthma.org.uk/advice/severe-asthma/what-is-severe-asthma/#:~:text=Severe%20asthma%20is%20the%20most,with%20high%20doses%20of%20medicines Last accessed September 2022.

[4] Asthma + Lung UK. 75% of people with severe asthma need regular emergency care, new Asthma UK survey finds. Available at: https://www.asthma.org.uk/about/media/news/75-of-people-with-severe-asthma-need-regular-emergency-care-new-asthma-uk-survey-finds/ Last accessed September 2022.

[5] Corren J, et al. Tezepelumab in Adults with Uncontrolled Asthma. N Engl J Med. 2017;377:936–946.

[6] British Lung Foundation. Asthma statistics. Available at: https://statistics.blf.org.uk/asthma Last accessed September 2022.

[7] Asthma UK. Slipping through the net: The reality facing patients with difficult and severe asthma. Available at: auk-severe-asthma-gh-final.pdf Last accessed September 2022.

[8] Menzies-Gow A, et al. Tezepelumab in Adults and Adolescents with Severe, Uncontrolled Asthma. (Supplementary Appendix). N Engl J Med. 2021;384:s1-s60.