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FDA grants Breakthrough Therapy Designation to tezepelumab for severe asthma
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Tezepelumab was recently granted FDA Breakthrough Therapy Designation for treating patients with severe asthma without an eosinophilic phenotype, AstraZeneca and Amgen announced.
“Tezepelumab is exciting because it has the potential to treat a broad population of severe asthma patients, including those ineligible for currently-approved biologic therapies,” Sean Bohen, executive vice president, global medicines development and chief medical officer at AstraZeneca, said in a press release.
The designation was based on the Phase 2b PATHWAY trial. The trial evaluated safety and effectiveness of three-dose regimens of tezepelumab as an add-on therapy compared with placebo among patients with a history of asthma exacerbations and uncontrolled asthma who received inhaled corticosteroids/long-acting beta-agonists with or without oral corticosteroids and additional asthma controllers, according to the release.
Participants received either 70 mg of tezepelumab every 4 weeks (low dose), 210 mg every 4 weeks (medium dose), 280 mg every 2 weeks (high dose) or placebo every 2 weeks.
The researchers found that compared with placebo, the low dose of tezepelumab reduced the annual asthma exacerbation rate by 62%, the medium dose reduced the rate by 71% and the high dose reduced the rate by 66%. The findings were independent of baseline blood eosinophil count or other type 2 inflammatory biomarkers, according to the release.
Nasopharyngitis, headaches, bronchitis and asthma-related side effects were the most common adverse events linked to tezepelumab.
Tezepelumab may be a first-in-class new medicine, according to the manufacturers. The agent blocks thymic stromal lymphopoietin which is an epithelial cytokine that plays a significant role in the initiation and persistence of airway inflammation, according to the manufacturers.
“The Phase 2b PATHWAY trial data demonstrated tezepelumab’s promise as a novel therapeutic option for a broad population of patients with severe asthma, including those ineligible for currently approved biologic therapies,” David M. Reese, MD, executive vice president of Research and Development at Amgen, said in a separate release. “The Breakthrough Designation will give us the opportunity to work closely with the FDA to bring tezepelumab to patients as quickly as possible.”
Disclosures: Bohen is employed by AstraZeneca. Reese is employed by Amgen.
Perspective
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Sumita Khatri, MD, MS
Rigorous evaluation of the roles of biologic therapies in asthma is essential. Now with breakthroughs in asthma research, we are able to see how the theoretical benefits of such agents translate to true clinical benefits for patients.
Specifically, tezepelumab blocks the thymic stromal lymphopoietin pathway, which we know results in reduction of asthma exacerbations in eosinophilic asthma. Also, by blocking thymic stromal lymphopoietin, tezepelumab has a higher upstream role in asthma inflammation and therefore, may have benefit beyond agents blocking only one inflammatory signal. This must be studied in a rigorous manner in patients with asthma, and the outcomes we as clinicians hope to see include reducing severity of asthma flare-ups, improving quality of life, improving lung function and reducing the need for systemic steroids.
With the breakthrough therapy designation, we hope to see more expeditious study of the efficacy and outcomes in patients with asthma even outside of the eosinophilic phenotype.
Because of its more upstream blocking capability in airway inflammation, tezepelumab and similar agents when discovered have poised themselves to be efficacious in severe asthma outside of the eosinophilic phenotype. There is a paucity of agents in the area of non-eosinophilic asthma and patients, to achieve control, may need to be on chronic oral steroids which result in significant side effects.
Laboratory studies have already demonstrated that nonallergic triggers of asthma such as viral infections and pollutants may cascade an asthma inflammatory pathway through the thymic stromal lymphopoietin mediator from airway cell exposure to those factors. Therefore, the ability of patients to improve asthma control can theoretically be improved in patients with asthma from non-allergic triggers.
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