TEZSPIRE approved by the U.S. FDA to treat severe asthma

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TEZSPIRE is currently available for shipping to wholesalers in the United States, according to Amgen and AstraZeneca. The US Food and Drug Administration (FDA) approved TEZSPIRE for the sustained treatment of severe asthma in adults and children aged 12 and above on December 17, 2021.

TEZSPIRE is a first-in-class biologic for severe asthma that targets thymic stromal lymphopoietin and epithelial cytokine at the top of the inflammatory cascade.TEZSPIRE is the first and only biologic for severe asthma with no eosinophilic or allergic phenotypic or biomarker restrictions in its approved label.

TEZSPIRE consistently and considerably lowered asthma attacks in a large group of severe asthma patients in Phase 2 and 3 clinical studies, regardless of critical indicators such as blood eosinophil counts, allergic status, or fractional exhaled nitric oxide. Pharyngitis, arthralgia, and back pain are the most prevalent TEZSPIRE side effects (incidence 3% and more common than placebo).

“Severe asthma has historically been a complex disease for patients to manage and for physicians to treat. About 60 percent of people have multiple drivers of disease and may not respond well to existing treatments. TEZSPIRE was approved for a broad population of people living with severe asthma, and we look forward to getting this important medicine into the hands of millions of patients who have had an unmet medical need,”

said Murdo Gordon, executive vice president of Global Commercial Operations at Amgen.

Amgen and AstraZeneca are dedicated to providing TEZSPIRE to qualified patients who have been prescribed it at a reasonable cost. The Tezspire Together Program provides product resources and support to providers and patients, including information on coverage, payment, and distribution. 

Amgen and AstraZeneca also provide patient help for TEZSPIRE through the Tezspire Patient Assistance Program, which provides free medicines to people who have no or restricted drug coverage. Patients and carers can contact Tezspire Together for further information.

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