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FDA Approves AstraZeneca and Amgen’s Pre-Filled Pen for Asthma

February 6, 2023

The FDA has approved AstraZeneca and Amgen’s Tezspire (tezepelumab-ekko), a self-administration pre-filled pen for patients aged 12 years and older with severe asthma.

The combination drug-device product approval was supported by results from a clinical trial in which 92 percent of healthcare providers, patients and caregivers were able to successfully administer Tezspire in the clinic and at home. 

The Tezspire pre-filled pen is also approved in the EU for self-administration.

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