The analysis showed tezepelumab achieved an 86% reduction in the annualized asthma exacerbation rate with patients having nasal polyps, and 52% in patients not having nasal polyps.
Amgen’s tezepelumab has displayed potential for treating severe asthma. (Al Seib / Los Angeles Times via Getty Images)
Tezepelumab is showing potential as a new biological therapy for severe refractory asthma. Though there is preliminary data from randomized clinical trials to suggest that the experimental drug, being developed by Amgen and AstraZeneca, is safe and effective for patients with severe, uncontrolled asthma, new data from the pivotal Navigator Phase III trial reaffirms it.
The data analysis, announced Sunday, demonstrated that tezepelumab reduced exacerbations and improved lung function and nasal symptoms in patients with comorbid nasal polyps.
The novel drug, being co-developed as part of a collaboration between the pharma giants, offers hope to the one in five people with severe asthma who also have nasal polyps. The U.S. Food and Drug Administration (FDA) accepted the Biologics License Application (BLA) and granted Priority Review for tezepelumab in early July. The drug had previously received Breakthrough Therapy Designation for patients with severe asthma without an eosinophilic phenotype in 2018.
At the time, Mene Pangalos, AstraZeneca’s EVP, BioPharmaceuticals R&D said it has the potential to transform treatment for a broad population of severe asthma patients.
The pair are developing tezepelumab in hopes of identifying a new class of human monoclonal antibodies that can target the primary site of inflammation, the airways, where viruses and allergens are inhaled.
The novel biologic reduced exacerbations by 56%, according to a study published in The New England Journal of Medicine, with the Navigator data reinforcing that tezepelumab is the only biologic to reduce exacerbations consistently and significantly in a wide sampling of this group.
The pre-specified exploratory analysis evaluated the effect of tezepelumab in patients with or without reported nasal polyps in the past two years. The review showed tezepelumab achieved an 86% reduction in the annualized asthma exacerbation rate with patients having nasal polyps, and 52% in patients not having nasal polyps.
Tezepelumab improved lung function and achieved a clinically relevant improvement in nasal polyp symptoms at week 52 in both groups of patients.
The drug blocks thymic stromal lymphopoietin (TSLP), which is at the top of numerous inflammatory cascades and triggers an overreactive immune response in allergic, eosinophilic, and other types of asthmatic inflammation. TSLP levels are correlated with disease severity, airway obstruction, and resistance to glucocorticoids.
Blocking TSLP may prevent the release of pro-inflammatory cytokines by immune cells, resulting in the prevention of asthma exacerbations and improved asthma control. By working at the top of the cascade, tezepelumab helps stop inflammation at the source and has the potential to treat a broad population of severe asthma patients.
Approximately 2.5 million people suffer from severe asthma worldwide, including about one million Americans. Currently available biologics and oral corticosteroids do not effectively control severe asthma. Additionally, a significant proportion of asthmatics have comorbid nasal polyps that may lead to breathing problems or negatively affect the quality of their lives, such as a reduction in sense of smell, sleep disturbances and a reduction in immunity.
It is here that Amgen and AstraZeneca appear to have scored, with their Navigator and Path Finder clinical trial program, establishing the case for what they believe will be a blockbuster asthma drug.
Analysts have estimated that peak sales could amount to $2 billion, and by 2026, GlobalData anticipates that the drug will bring in $1.8 billion from worldwide sales.
Welcoming the results, Dr. David Reese, EVP of research and development at Amgen said the results further strengthened the firm’s confidence in tezepelumab’s potential to address a significant unmet need.
Authorized medicines to treat severe, uncontrolled asthma include GlaxoSmithKline‘s Nucala, Sanofi and Regeneron Pharmaceuticals’ Dupixent and AstraZeneca’s Fasenra, but these are only approved for patients with high levels of eosinophils.
Tezepelumab, an injectable subcutaneous monoclonal antibody, is one of the more advanced monoclonal antibodies that blocks TSLP.
Recent clinical and immunological phenotypic classifications of asthma have encouraged the development of new therapeutic strategies, such as the discovery of monoclonal antibodies targeted to IgE (anti-IgE/omalizumab), or anti-interleukin-5 (IL-5), specific for the Type 2 (T2)-high eosinophilic phenotype. Anti-IgE therapy with omalizumab was the first therapeutic option for the treatment of severe allergic asthma.
Anti-IL-5 biologics such as mepolizumab, reslizumab and anti-IL-5 receptor alpha subunit such as benralizumab have recently been approved as add-on treatments in patients with severe eosinophilic refractory asthma. To date, other drugs are being developed aimed at treating the T2-high phenotype.
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