FDA approves pre-filled tezepelumab pen for severe asthma in adolescents


The US Food and Drug Administration has approved the use of a pre-filled tezepelumab (TEZSPIRE; Amgen and AstraZeneca) pen in patients aged 12 years and older with severe asthma.

Tezepelumab (TEZSPIRE; Amgen and AstraZeneca) pre-filled pen has been approved by the US Food and Drug Administration (FDA) for treatment of severe asthma in pediatric patients aged 12 years and older.

After the original FDA approval for tezepelumab in 2021, the recent approval allows the use of a pre-filled pen for asthma treatment.

About 2.5 million individuals worldwide experience severe asthma, 1.3 million of which are in the United States. Maintaining asthma control is difficult in many of these patients because of an inadequate response to biologics and oral corticosteroids which are currently available.

Tezepelumab is a self-administered, single use pen and currently the only biological approved for severe asthma with no phenotype. It was approved after the PATHFINDER clinical trial program, which included the PATH-BRIDGE phase 1 trial and the PATH-HOME phase 3 trial.

Administration of tezepelumab was successful from 92% of providers, patients, and caregivers, both at home and in the clinic. Safety and efficacy outcomes were consistent with those observed in prior clinical trials.

"Severe asthma continues to be a very complex condition to manage," said Kenneth Mendez, president and CEO of the Asthma and Allergy Foundation of America. Mendez stated self-administration could be a key factor in addressing unmet needs for individuals with severe asthma.

Thymic stromal lymphopoietin (TSLP) is anepithelial cytokine present at the top of multiple inflammatory cascades. In severe asthma, it causes the immune system to overreact to types of airway inflammation. Tezepelumab blocks TSLP, reducing this reaction.

Pharyngitis, arthralgia, and back pain were the most common adverse reactions from tezepelumab, with an incidence of 3% or more. Other observed adverse reactions include hyposensitivity reactions such as rash and allergic conjunctivitis, along with postmarketing cases of anaphylaxis.

The FDA granted an Orphan Drug designation to tezepelumab for treating eosinophilic esophagitisin October 2021. Amgen plans to develop the drug for other indications such as chronic obstructive pulmonary disease, chronic spontaneous urticaria, and chronic rhinosinusitis with nasal polyps.


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

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