www.fdanews.com/articles/211050-fda-approves-astrazeneca-and-amgens-pre-filled-pen-for-asthma
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.