AstraZeneca (AZ) and Amgen’s Tezspire (tezepelumab) has been recommended for use within the NHS in England and Wales as a maintenance treatment for certain adults and adolescents aged 12 years and above with severe asthma.
The final draft guidance from the National Institute for Health and Care Excellence (NICE) specifically applies to patients who are inadequately controlled with high dose inhaled corticosteroids plus another maintenance therapy. Eligible patients will have had three or more exacerbations in the previous year, or are having maintenance oral corticosteroids.
The decision was supported by positive data from the PATHFINDER clinical trial programme, including one phase 3 study which demonstrated a 56% reduction in the annualised asthma exacerbation rate in these patients receiving Tezspire compared to placebo.
The therapy also demonstrated improvements in every key secondary endpoint compared to baseline, including lung function, asthma control and health related quality of life.
Due to the complexity of severe asthma, many patients have unclear or multiple drivers of airway inflammation, resulting in some not responding to the current standard of care.
Tezspire is the only biologic that targets TSLP, shown to play a key role in multiple inflammatory pathways in the condition. By blocking the action of TSLP, Tezspire helps to suppress inflammation that contributes to asthma symptoms and exacerbations.
“Many with severe uncontrolled asthma have multiple inflammatory drivers of disease and [Tezspire’s] unique mechanism of action means it has the potential to treat a broad population of patients, irrespective of inflammatory phenotype,” explained David Jackson, professor of respiratory medicine and clinical lead for Guy’s and St Thomas’ Asthma Service.
AZ estimates that approximately 98,000 patients in England and Wales who live with severe uncontrolled asthma may be eligible for the new treatment.
Tom Keith-Roach, president of AZ UK, said: “This is an important step towards [Tezspire] being considered for use in the treatment of eligible UK patients with severe uncontrolled asthma regardless of biomarker status or phenotype, opening up biologics as a treatment option for many patients across England and Wales who were historically ineligible.”
The recommendation builds on the recent UK approval of AZ’s Symbicort as the first and only combination reliever therapy for adults and adolescents aged 12 years and above with mild asthma.