Policy & Regulation
Tezspire Now Available in the United States for the Treatment of Severe Asthma
14 January 2022 - - Tezspire (tezepelumab-ekko) is now available for shipment to wholesalers in the US, British-Swedish multinational pharmaceutical and biotechnology company AstraZeneca (NASDAQ: AZN) and US-based biopharmaceutical company Amgen (NASDAQ: AMGN) said.

Tezspire was approved by the US Food and Drug Administration on December 17, 2021 for the add-on maintenance treatment of adult and pediatric patients aged 12 years and older with severe asthma.

Tezspire is a first-in-class biologic for severe asthma that acts at the top of the inflammatory cascade by targeting thymic stromal lymphopoietin, an epithelial cytokine.

Tezspire is the first and only biologic approved for severe asthma with no phenotype (e.g. eosinophilic or allergic) or biomarker limitation within its approved label.

Tezspire consistently and significantly reduced asthma exacerbations across Phase II and III clinical trials which included a broad population of severe asthma patients irrespective of key biomarkers, including blood eosinophil counts, allergic status and fractional exhaled nitric oxide.

In clinical studies, the most common adverse reactions in patients who received TEZSPIRE were pharyngitis, arthralgia and back pain.

The Tezspire Together Program offers provider and patient product resources and support, including information related to coverage, reimbursement and distribution.

AstraZeneca and Amgen also provide patient assistance for Tezspire for qualifying individuals with no or limited drug coverage by providing free medicines through the Tezspire Patient Assistance Program.

Tezspire (tezepelumab) is being developed by AstraZeneca in collaboration with Amgen as a first-in-class human monoclonal antibody that inhibits the action of TSLP, a key epithelial cytokine that sits at the top of multiple inflammatory cascades and is critical in the initiation and persistence of allergic, eosinophilic and other types of airway inflammation associated with severe asthma, including airway hyperresponsiveness.

TSLP is released in response to multiple triggers associated with asthma exacerbations, including allergens, viruses and other airborne particles.

Expression of TSLP is increased in the airways of patients with asthma and has been correlated with disease severity.

Blocking TSLP may prevent the release of pro-inflammatory cytokines by immune cells, resulting in the prevention of asthma exacerbations and improved asthma control.

Tezspire acts at the top of the inflammation cascade and has the potential to help address a broad population of severe asthma patients irrespective of biomarker levels.

Tezspire is also in development for other potential indications including chronic obstructive pulmonary disease, chronic rhinosinusitis with nasal polyps, chronic spontaneous urticaria and eosinophilic esophagitis.

In October 2021, tezepelumab was granted Orphan Drug Designation by the FDA for the treatment of EoE.

In 2020, AstraZeneca and Amgen updated a 2012 collaboration agreement for Tezspire. Both companies will continue to share costs and profits equally after payment by AstraZeneca of a mid single-digit inventor royalty to Amgen. AstraZeneca continues to lead development and Amgen continues to lead manufacturing. All aspects of the collaboration are under the oversight of joint governing bodies.

Under the amended agreement, AstraZeneca and Amgen will jointly commercialize Tezspire in North America.