Regulatory Decision Summary for Tezspire

• Asthma is a heterogeneous disease characterized by chronic variable and reversible airflow obstruction, bronchial hyper-responsiveness, and chronic airway inflammation. Despite affecting a minority of asthmatics, severe asthma affects 150,000-250,000 Canadians, and this population of asthmatics is at the greatest risk of severe exacerbation and mortality.
• Authorization was based on three international, multi-centre, randomized, double-blind, placebo-controlled trials investigating tezepelumab as an add-on maintenance treatment in adults and adolescents 12 years and older with severe asthma; two of these were asthma exacerbation studies (NAVIGATOR [pivotal study] and PATHWAY [dose ranging]) and one was an oral corticosteroid (OCS)-reduction study (SOURCE).
• In the pivotal trial, NAVIGATOR, tezepelumab resulted in a clinically and statistically significant reduction in the annualised asthma exacerbation rate (AAER) over 52 weeks in 1,059 subjects with inadequately-controlled asthma. The reduction in AAER in subjects treated with tezepelumab was consistent across baseline eosinophil levels and other clinically relevant subgroups. Efficacy results from 82 adolescent subjects were consistent with a clinically meaningful reduction in AAER associated with tezepelumab treatment.
• The risks associated with tezepelumab were primarily based upon a pooling of two trials, NAVIGATOR and PATHWAY. The overall incidence of adverse events was similar between treatment groups and most commonly included nasopharyngitis, upper respiratory tract infection, headache, and asthma; more subjects in the placebo group experienced serious adverse events compared to the tezepelumab group. Based on data submitted from an extension trial, there was an imbalance in serious cardiac adverse events associated with tezepelumab treatment; however, there does not appear to be a causal link between these observations and tezepelumab.
• The recommended dose of the drug is 210 mg by subcutaneous injection every 4 weeks (Q4W). View the Product Monograph for details.
• Overall, based on the data evaluated as part of this submission, the Biologic and Radiopharmaceutical Drugs Directorate (BRDD) considers there to be sufficient evidence at this time to conclude that the benefit-risk profile for Tezspire (tezepelumab injection) as an add-on maintenance treatment in adults and adolescents 12 years and older with severe asthma is considered favourable.

For more information on Health Canada’s decision, please view the Summary Basis of Decision.