Amgen announced that the US 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.

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.

"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 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 is a first-in-class biologic for severe asthma that 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). 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.

"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 chief executive officer at the Allergy & Asthma Network (AAN) and president of the Global Allergy and Airways Patient Platform (GAAPP). "For the first time, many people living with severe asthma have the opportunity to receive treatment regardless of the cause of their inflammation."