FDA Approves Tezepelumab Self-Administration for Severe Asthma


The biologic from Amgen and AstraZeneca was approved for self-administration in a pre-filled, single-use pen for patients aged 12 years and older with severe asthma.

The US Food and Drug Administration (FDA) has approved tezepelumab-ekko (TEZSPIRE®) for self-administration in a pre-filled, single-use pen for patients aged 12 years and older with severe asthma.1

Announced by Amgen and AstraZeneca in a statement on Feburary 2, the therapy was first approved by the FDA in December 2021.2 It is the only biologic approved for severe asthma with no phenotype of biomarker limitation within its approved label, according to the release. This approval now offers patients the choice of administration at home or in a doctor’s office.

"People with severe asthma will now have the flexibility to administer TEZSPIRE at home or continue to receive their medicine in their doctor's office," said Murdo Gordon, executive vice president of Global Commercial Operations at Amgen in a statement.1 "This approval reinforces our continued efforts to improve accessibility to TEZSPIRE, a first-in-class medicine proven to consistently and significantly reduce exacerbations across a broad population of people with severe asthma."

Its FDA approval was based on results from the PATHFINDER clinical trial program, which itself included findings from the PATH-BRIDGE Phase 1 trial and the PATH-HOME Phase 3 trial. Data show the majority (92%) of healthcare providers, patients and caregivers were able to successfully administer tezepelumab-ekko both in the clinic and at-home during the PATH-HOME trial.

The release additionally noted the improvements in asthma control and the safety profile of tezepelumab-ekko seen in the PATH-HOME trial were consistent with findings of previous clinical trials. The most common adverse reactions of the therapy were pharyngitis, arthralgia, and back pain.

“Severe asthma continues to be a very complex condition to manage, so we welcome the TEZSPIRE pre-filled pen as an option that will empower patients and healthcare providers with increased choice,” said Kenneth Mendez, president and chief executive officer of the Asthma and Allergy Foundation of America in a statement.1 “We believe self-administration alternatives can play an important role in patients’ lives and address unmet needs for those living with severe asthma.”

The biologic is a first-in-class human monoclonal antibody focusing on the primary source of inflammation, the airway epithelium. It targets and blocks TSLP,a key epithelial cytokine that sits at the top of multiple inflammatory cascades and initiates an overreactive immune response to allergic, eosinophilic and other types of airway inflammation associated with severe asthma.

The therapy is indicated for the add-on maintenance treatment of adult and pediatric patients aged 12 years and older with severe asthma in the United States. Self-administration of tezepelumab-ekko and pre-filled pens are also approved in the European Union (EU) and under regulatory review in other countries across the globe.


1. TEZSPIRE® approved for self-administration in the U.S. with a new pre-filled pen. Amgen. https://www.amgen.com/newsroom/press-releases/2023/02/tezspire-approved-for-self-administration-in-the-u-s--with-a-new-pre-filled-pen. Accessed February 2, 2023.

2. FDA approves TEZSPIRE™ (tezepelumab-ekko) in the U.S. for severe asthma. Amgen. https://www.amgen.com/newsroom/press-releases/2021/12/fda-approves-tezspire-tezepelumabekko-in-the-us-for-severe-asthma. Published December 17, 2021. Accessed February 2, 2023.

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