AstraZeneca PLC (LSE:AZN) said its Tezspire drug, developed in collaboration with Amgen, Inc, has been approved in the US for treatment of severe asthma in patients older than 12 years.
Tezspire (tezepelumab-ekko) was approved following a Priority Review by the US Food and Drug Administration (FDA) and based on results from the PATHFINDER clinical trial programme and the pivotal NAVIGATOR Phase III trial, in which Tezspire demonstrated superiority across every primary and key secondary endpoint in patients with severe asthma, AstraZeneca said in a statement.
Tezspire is the first and only biologic to consistently and significantly reduce asthma exacerbations in a broad population of severe asthma patients and is the only biologic approved for severe asthma with no phenotype or biomarker limitation, the company noted.
Asthma affects around 339 million people worldwide, with around 10% of patients suffering from severe asthma.
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Professor Andrew Menzies-Gow, director of the lung division at Royal Brompton Hospital in London and principal investigator of the NAVIGATOR trial, said: "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 hospitalisation and a significantly reduced quality of life.
“Tezspire represents a much-needed new treatment for the many patients who remain underserved and continue to struggle with severe, uncontrolled asthma."
Tonya Winders, president and CEO of Allergy & Asthma Network, and president of the Global Allergy and Airways Patient Platform, added: "The approval of Tezspire is long-awaited positive news for the asthma community. For the first time, many people living with severe asthma have the opportunity to receive treatment regardless of the cause of their inflammation."
Mene Pangalos, executive vice president, BioPharmaceuticals R&D, AstraZeneca, said: "Today's positive decision marks the first time the FDA has approved a biologic for asthma without phenotypic limitation and irrespective of biomarker levels. With the approval of Tezspire, 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."
Tezspire is under regulatory review in the EU, Japan and several other countries around the world.