FDA Approves SQ Biologic for Severe Asthma – Tezspire


The FDA approved a new, subcutaneous biologic last week, Tezspire (tezepelumab-ekko) from Amgen and AstraZeneca, an add-on maintenance treatment for adult and pediatric patients (12+) with severe asthma. Tezspire is a first-in-class biologic for this complex condition.

Severe asthma impacts many of the 34 million people living with the disease worldwide. It affects their breathing and can severely limit day-to-day activity. The treatment has proven effective across a spectrum of causes of inflammation (but not indicated for acute bronchospasm or status asthmaticus).

Tezspire is the result of a collaboration agreement by Amgen and AstraZeneca that started in 2012. The companies will share costs and profits equally. AstraZeneca will lead development and Amgen will lead manufacturing. Amgen and AstraZeneca will jointly commercialize Tezspire in the US. Tezspire will enter the segment now led by Xolair (omalizaub) for patients with allergic asthma and Dupixent (dupilumab) for patients with eosinophilic asthma. Analysts forecast Teszpire to break the $$billion mark within three years of launch.

Tezspire will enter the market at an anticipated price of $28,000 per year. Distribution details were not released. Given that both Xolair and Dupixent are only available through limited distribution it is likely that Tezspire will also launch through LD.

FDA Approves Tezspire (tezepelumab-ekko) in the U.S. for Severe Asthma

First and Only Biologic to Consistently and Significantly Reduce Exacerbations in a Broad Population of Severe Asthma Patients
Only Biologic for Severe Asthma Approved With no Phenotype or Biomarker Limitations

THOUSAND OAKS, Calif., Dec. 17, 2021 /PRNewswire/ — Amgen today announced that the U.S. Food and Drug Administration (FDA) has approved Amgen and AstraZeneca’s Tezspire™ (tezepelumab-ekko) for the add-on maintenance treatment of adult and pediatric patients aged 12 years and older with severe asthma.1

Tezspire was approved following a Priority Review by the FDA and based on results from the PATHFINDER clinical trial program. The application included results from the pivotal NAVIGATOR Phase 3 trial in which Tezspire demonstrated superiority across every primary and key secondary endpoint in patients with severe asthma, compared to placebo, when added to standard therapy.2

“Today’s approval by the FDA marks the first time that patients and their physicians will have a biologic option for severe asthma without phenotypic limitations and irrespective of biomarker levels,” said David M. Reese, M.D., executive vice president of Research and Development at Amgen. “Asthma is a complex and chronic inflammatory disease that affects everyone differently. By working at the top of the inflammation cascade, Tezspire helps stop the inflammation that causes asthma attacks at the source and has the potential to treat a broad population of people with severe asthma, including those who have historically lacked effective treatment options.”

Tezspire acts at the top of the inflammatory cascade by targeting thymic stromal lymphopoietin (TSLP), an epithelial cytokine.3 It is the first and only biologic to consistently and significantly reduce asthma exacerbations across Phase 2 and 3 clinical trials, which included a broad population of severe asthma patients irrespective of key biomarkers, including blood eosinophil counts, allergic status and fractional exhaled nitric oxide (FeNO).2,3 Tezspire is the first and only biologic for severe asthma that does not have a phenotype—eosinophilic or allergic—or biomarker limitation within its approved label.4-11

“Due to the complex and heterogeneous nature of severe asthma and despite recent advances, many patients continue to experience frequent exacerbations, an increased risk of hospitalization and a significantly reduced quality of life,” said Professor Andrew Menzies-Gow, director of the Lung Division, Royal Brompton Hospital, London, UK, and the principal investigator of the NAVIGATOR trial. “Tezspire represents a much-needed new treatment for the many patients who remain underserved and continue to struggle with severe, uncontrolled asthma.”

Results from the NAVIGATOR Phase 3 trial were published in The New England Journal of Medicine in May 2021.2 In clinical studies of Tezspire, the most common adverse reactions were nasopharyngitis, upper respiratory tract infection and headache.


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