Amgen, AstraZeneca secure FDA approval for Tezspire

Tezspire is a first-in-class biologic for severe asthma that acts at the top of the inflammatory cascade by targeting thymic stromal lymphopoietin, an epithelial cytokine.

Sandra Levy

1/7/2022

Amgen and AstraZeneca have received the Food and Drug Administration’s clearance for Tezspire (tezepelumab-ekko) for the add-on maintenance treatment of adult and pediatric patients aged 12 years and older with severe asthma.

“Today's approval by the FDA marks the first time patients and their physicians will have a biologic option for severe asthma without phenotypic limitations and irrespective of biomarker levels," said David Reese, Amgen executive vice president of research and development. "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."

"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."

"Severe asthma continues to have a debilitating impact on many of the 34 million people living with the disease worldwide, affecting their breathing and limiting aspects of day-to-day life. The approval of Tezspire is long-awaited positive news for the asthma community," said Tonya Winders, president and CEO at the Allergy & Asthma Network and president of the Global Allergy and Airways Patient Platform. "For the first time, many people living with severe asthma have the opportunity to receive treatment regardless of the cause of their inflammation."

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