Tezspire Approved as Pre-filled Pen for Asthma

FDA has approved AstraZeneca and Amgen’s Tezspire (tezepelumab) in a self-administration pre-filled, single-use pen for patients aged 12 years and older with severe asthma. Approval was based on data from the PATHFINDER clinical trial program, which showed that the majority (92%) of healthcare providers, patients and caregivers were able to successfully administer the drug in the clinic and at home, the company says. Tezspire was approved in 2021 as a subcutaneous injection add-on maintenance treatment for adult and pediatric patients.

The companies say Tezspire is the “first and only biologic approved for patients with severe asthma with no phenotype or biomarker limitation within its approved label. With the approval of the pre-filled pen in the U.S., we can now offer greater flexibility to patients and physicians with the option to administer Texspire at home or in the clinic.”