FDA Approves AstraZeneca and Amgen’s Tezpire

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Tezpire (tezepelumab-ckko) has been approved as an add-on maintenance treatment for severe asthma.

AstraZeneca and Amgen announced on Dec. 17, 2021, that FDA approved Tezspire (tezepelumab-ckko) as an add-on maintenance treatment for severe asthma in patients aged 12 years and older. According to an AstraZeneca press release, clinical trial data showed that tezepelumab-ckko is the first biologic to reduce asthma exacerbations consistently and significantly in a broad population of patients with severe asthma.

Tezepelumab-ckko is a first-in-class biologic that was developed through a collaboration between AstraZeneca and Amgen that began in 2012. The drug functions by targeting thymic stromal lymphopoietin (TLSP), an epithelial cytokine. By inhibiting the action of TLSP, it can prevent the initiation and persistence of allergic, eosinophilic, and other types of airway inflammation associated with severe asthma, including airway hyperresponsiveness.

FDA made the decision following publication of results from the NAVIGATOR study, a Phase III, randomized, double-blinded, placebo-controlled trial in adults aged 18–80. The trial measured the annualized rate of asthma exacerbations, finding that patients who received tezepelumab-ckko had a rate of 0.93, while those given placebo had a rate of 2.10. Results from two other trials, PATHWAY and SOURCE, were also considered.

“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 Andrew Menzies-Gow, director of the lung division, Royal Brompton Hospital, and principal investigator of the NAVIGATOR trial, in the release. “[Tezepelumab-ckko] represents a much-needed new treatment for the many patients who remain underserved and continue to struggle with severe, uncontrolled asthma.”


“Today’s positive decision marks the first time the FDA has approved a biologic for asthma without phenotypic limitation and irrespective of biomarker levels,” said Mene Pangalos, executive vice-president, biopharmaceuticals R&D, AstraZeneca, in the release. “With the approval of [tezepelumab-ckko], physicians will now be able to offer an important new treatment that has the potential to transform care for a broad population of severe asthma patients.”

Source: AstraZeneca