TEZSPIRE™ (TEZEPELUMAB-EKKO) NOW AVAILABLE IN THE UNITED STATES FOR THE TREATMENT OF SEVERE ASTHMA
THOUSAND OAKS, Calif., Jan. 13, 2022 /PRNewswire/ -- Amgen (NASDAQ:AMGN) and AstraZeneca today announced TEZSPIRE™ (tezepelumab-ekko) is now available for shipment to wholesalers in the U.S. TEZSPIRE was approved by the U.S. Food and Drug Administration (FDA) on Dec. 17, 2021 for the add-on maintenance treatment of adult and pediatric patients aged 12 years and older with severe asthma.1
"Severe asthma has historically been a complex disease for patients to manage and for physicians to treat," said Murdo Gordon, executive vice president of Global Commercial Operations at Amgen. "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."
TEZSPIRE is a first-in-class biologic for severe asthma that acts at the top of the inflammatory cascade by targeting thymic stromal lymphopoietin (TSLP), an epithelial cytokine.2 TEZSPIRE is the first and only biologic for severe asthma that does not have a phenotype—eosinophilic or allergic—or biomarker limitation within its approved label.4-11 TEZSPIRE consistently and significantly reduced asthma attacks across Phase 2 and 3 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 (FeNO).2,3
The most common adverse reactions (incidence ≥3% and more common than placebo) of TEZSPIRE are pharyngitis, arthralgia, and back pain.1
Amgen and AstraZeneca are committed to providing appropriate patients who are prescribed TEZSPIRE with affordable access to the medicine. The Tezspire Together Program offers provider and patient product resources and support, including information related to coverage, reimbursement and distribution. For more information about the Tezspire Together Program, call 1-888-TZSPIRE (1-888-897-7473) or visit Tezspire.com.
Amgen and AstraZeneca 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. For additional information, patients and caregivers may contact Tezspire Together.
TEZSPIRE™ (tezepelumab-ekko) U.S. Indication
TEZSPIRE is not indicated for the relief of acute bronchospasm or status asthmaticus.
TEZSPIRE™ (tezepelumab-ekko) Important Safety Information
WARNINGS AND PRECAUTIONS
Acute Asthma Symptoms or Deteriorating Disease
Abrupt Reduction of Corticosteroid Dosage
Parasitic (Helminth) Infection
Live Attenuated Vaccines
USE IN SPECIFIC POPULATIONS
Please see the TEZSPIRE full Prescribing Information.
You may report side effects related to AstraZeneca products by clicking here.
About the NAVIGATOR and the PATHFINDER Clinical Trial Program
NAVIGATOR is a Phase 3, randomized, double-blinded, placebo-controlled trial in adults (18–80 years old) and adolescents (12–17 years old) with severe, uncontrolled asthma, who were receiving standard of care (SoC). SoC was treatment with medium- or high-dose inhaled corticosteroids (ICS) plus at least one additional controller medication with or without daily oral corticosteroid treatment. The trial population included approximately equal proportions of patients with high (≥300 cells per microliter) and low (<300 cells per microliter) blood eosinophil counts. The trial comprised a five-to-six-week screening period, a 52-week treatment period and a 12-week post-treatment follow-up period. All patients received their prescribed controller medications without change throughout the trial.2
The primary efficacy endpoint was the AAER during the 52-week treatment period. Key secondary endpoints included the effect of TEZSPIRE on lung function, asthma control and health-related quality of life.3
As part of prespecified analyses, the AAER over 52 weeks was also assessed in patients grouped by baseline blood eosinophil count, FeNO level and serum specific immunoglobin E (IgE) status (perennial aeroallergen sensitivity positive or negative).3 These are inflammatory biomarkers used by clinicians to inform treatment options and involve tests analyzing a patient's blood (eosinophils/IgE) and exhaled air (FeNO).
The most frequently reported adverse events for TEZSPIRE were nasopharyngitis, upper respiratory tract infection and headache.2
NAVIGATOR is the first Phase 3 trial to show benefit in severe asthma irrespective of eosinophils by targeting TSLP.2 These results support the U.S. Food and Drug Administration Breakthrough Therapy Designation granted to TEZSPIRE in September 2018 for patients with severe asthma, without an eosinophilic phenotype. In July 2021, TEZSPIRE was the first and only biologic to be granted Priority Review in the U.S. for the treatment of asthma by the FDA.
Patients who participated in our Phase 3 clinical trials were eligible to continue in DESTINATION, a Phase 3 extension trial assessing long-term safety and efficacy.16
About TEZSPIRE™ (tezepelumab-ekko)
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 (EoE). In October 2021, tezepelumab was granted Orphan Drug Designation by the FDA for the treatment of EoE.
About Severe Asthma
Multiple inflammatory pathways are involved in the pathogenesis of asthma.27-29 Eosinophilic asthma, and more broadly, T2 inflammation-driven asthma, accounts for about two-thirds of patients with severe asthma.29 These patients are typically characterized as having elevated levels of inflammatory biomarkers, including blood eosinophils, serum IgE and FeNO.30,31 However, many patients do not fit the criteria for eosinophilic or allergic asthma, may have unclear or multiple drivers of inflammation, and may not qualify for or respond well to a current biologic medicine.31
About the Amgen and AstraZeneca Collaboration
Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.
Amgen is one of the 30 companies that comprise the Dow Jones Industrial Average and is also part of the Nasdaq-100 index. In 2021, Amgen was named one of the 25 World's Best Workplaces™ by Fortune and Great Place to Work™ and one of the 100 most sustainable companies in the world by Barron's.
For more information, visit www.amgen.com and follow us on www.twitter.com/amgen.
Amgen Forward-Looking Statements
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CONTACT: Amgen, Thousand Oaks
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