Tezspire Now Available In The United States For The Treatment Of Severe Asthma

NAVIGATOR is the first Phase III trial to show benefit in severe asthma irrespective of eosinophils by targeting TSLP.9 These results support the FDA 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 grantedPriority Reviewin the US for the treatment of asthma by the FDA. TEZSPIRE is a prescription medicine used with other asthma medicines for the maintenance treatment of severe asthma in people 12 years of age and older whose asthma is not controlled with their current asthma medicine.

  • These reprints may include some information about TEZSPIRE that is not contained in its FDA-approved Prescribing Information.
  • TEZSPIRE helps prevent severe asthma attacks and can improve your breathing.
  • The most common adverse reactions (incidence ≥3%) are pharyngitis, arthralgia, and back pain.
  • ¶Nurse educators are nurses by training, but they are not part of your treatment team or an extension of your doctor’s office.
  • Treat patients with pre-existing helminth infections before initiating therapy with TEZSPIRE.
  • The Company aims to transform the treatment of asthma and chronic obstructive pulmonary disease by focusing on earlier biology-led treatment, eliminating preventable asthma attacks, and removing COPD as a top-three leading cause of death.

We rely on collaborations with third parties for the development of some of our product candidates and for the commercialization and sales of some of our commercial products. In addition, we compete with other companies with respect to many of our marketed products as well as for the discovery and development of new products. Further, some raw materials, medical devices and component parts for our products are supplied by sole third-party suppliers. Certain of our distributors, customers and payers have substantial purchasing leverage in their dealings with us. The discovery of significant problems with a product similar to one of our products that implicate an entire class of products could have a material adverse effect on sales of the affected products and on our business and results of operations. Our efforts to collaborate with or acquire other companies, products or technology, and to integrate the operations of companies or to support the products or technology we have acquired, may not be successful.

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If patients become infected while receiving TEZSPIRE and do not respond to anti-helminth treatment, discontinue TEZSPIRE until infection resolves. Any reference in these archives to AstraZeneca products or their uses may not reflect current medical knowledge and should not be used as a source of information on the present product label, efficacy data or safety data. Please refer to your approved national product label for current product information.

It is unknown if TEZSPIRE will influence a patient’s response against helminth infections. In a mechanistic study ,9 airway hyperresponsiveness to mannitol, an exploratory outcome, was reduced in patients treated with TEZSPIRE 210 mg Q4W + SOC and placebo + SOC. There was a numerically greater reduction in AHR to mannitol in patients who received TEZSPIRE compared with those who received placebo, both in terms of absolute PD15 and in doubling doses. The clinical significance of this outcome and its impact on asthma have not been established.

Have recently received or are scheduled to receive any vaccinations. You should not receive a “live vaccine” if you are treated with TEZSPIRE. While her tezspire together art career takes off, Amaia has launched a niche dog-walking business, leveraging her low center of gravity, her love of dogs, and her artistic eye.

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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 grantedOrphan Drug Designationby the FDA for the treatment of EoE. 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. Despite available treatment, up to 1.3 million people have uncontrolled severe asthma. TEZSPIRE is indicated for the add-on maintenance treatment of adult and pediatric patients aged 12 years and older with severe asthma.

tezspire together

Some authors may have a financial interest in either TEZSPIRE or AstraZeneca and may have received compensation in connection with these studies or other engagements. In 2020, AstraZeneca and Amgen updated a2012 collaboration agreementfor TEZSPIRE. Both companies will continue to https://xcritical.com/ 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.

AstraZeneca recommends use of TEZPIRE only in accordance with its approved Prescribing Information. Prescription drugs used outside of an approved indication may not be eligible for reimbursement by third-party payors, including Medicare or Medicaid. AstraZeneca manufactures TEZSPIRE and provided sponsorship/funding for the studies discussed.

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Under the amended agreement, AstraZeneca and Amgen will jointly commercialize TEZSPIRE in North America. Amgen will record product sales in the US, with AZ recording its share of US profits as Collaboration Revenue. Outside of the US, AstraZeneca will record product sales, with Amgen recording profit share as Other/Collaboration revenue. TEZSPIRE helps prevent severe asthma attacks and can improve your breathing. That’s why we’re here to support you with tips, tools, personalized resources, and helpful answers to your questions. And our exclusive Spotify® playlist serves up a soothing soundtrack to help you on your journey back to being you.

This news release contains forward-looking statements that are based on the current expectations and beliefs of Amgen. It is unknown if TEZSPIRE will influence a patient’s response against helminth infections. Treat patients with pre-existing helminth infections before initiating therapy with TEZSPIRE.

You may report side effects related to AstraZeneca products by clicking here. Is greater during the third trimester of pregnancy; therefore, potential effects on a fetus are likely to be greater during the third trimester of pregnancy. This medicine is to be given only by or under the direct supervision of your doctor. 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.

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. Change or stop taking your other asthma medicines unless instructed to do so by your healthcare provider. TEZSPIRE should not be used to treat acute asthma symptoms, acute exacerbations, acute bronchospasm, or status asthmaticus.

Biologic Approved For Severe Asthma Without Phenotypic Or Biomarker Limitations1

The most common adverse reactions (incidence ≥3%) are pharyngitis, arthralgia, and back pain. #Nurse educators are nurses by training, but they are not part of your treatment team or an extension of your doctor’s office. †Nurse educators are nurses by training, but they are not part of your treatment team or an extension of your doctor’s office.

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These reactions can occur within hours of administration, but in some instances have a delayed onset . 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. AstraZeneca is an established leader in respiratory care with a 50-year heritage. The Company aims to transform the treatment of asthma and chronic obstructive pulmonary disease by focusing on earlier biology-led treatment, eliminating preventable asthma attacks, and removing COPD as a top-three leading cause of death. The Company’s early respiratory research is focused on emerging science involving immune mechanisms, lung damage and abnormal cell-repair processes in disease and neuronal dysfunction.

Support program (for eligible, commercially insured patients only†), and more. Hawk is a proud vegan with a soft spot for beautiful bouquets, botanical gardens, and furry animals. Although his severe asthma keeps him from actually owning a cat, he doesn’t let his love of adorable four-pawed creatures go unscratched. The concomitant use of TEZSPIRE and live attenuated vaccines has not been evaluated. The use of live attenuated vaccines should be avoided in patients receiving TEZSPIRE. TEZSPIRE is not indicated for the relief of acute bronchospasm or status asthmaticus.

This medicine will not relieve an asthma attack that has already started. 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. AstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialization of prescription medicines in Oncology, Rare Diseases and BioPharmaceuticals, including Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. Based in Cambridge, UK, AstraZeneca operates in over 100 countries, and its innovative medicines are used by millions of patients worldwide. Hypersensitivity reactions can occur following administration of TEZSPIRE.

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Adding plans allows you to compare formulary status to other drugs in the same class. You may report side effects related to AstraZeneca products by clickinghere. ¶Nurse educators are nurses by training, but they are not part of your treatment team or an extension of your doctor’s office. Talk to your healthcare provider about the best way to feed your baby if you use TEZSPIRE. Meet some characters who are living their lives with better control of their asthma.

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Amgen will record product sales in the U.S., with AstraZeneca recording its share of U.S. profits as Collaboration Revenue. Outside of the U.S., AstraZeneca will record product sales, with Amgen recording profit share as Other/Collaboration revenue. I have read this warning and will not be using any of the contained product information for clinical purposes. Program benefits at any time, including if your plan does not apply benefits to satisfy your out-of-pocket costs. The Spanish version of the adverse event reporting language is also available at this site.

Click here for additional CASCADE study information including limitations. Tezepelumab-ekko injection is used together with other medicines to treat severe asthma. Tezepelumab-ekko helps prevent severe asthma attacks and can improve your breathing.

A breakdown, cyberattack or information security breach could compromise the confidentiality, integrity and availability of our systems and our data. Our stock price is volatile and may be affected by a number of events. Global economic conditions may magnify certain risks that affect our business. Our business performance could affect or limit the ability of our Board of Directors to declare a dividend or our ability to pay a dividend or repurchase our common stock. We may not be able to access the capital and credit markets on terms that are favorable to us, or at all. “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.”

Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature. Tell your healthcare provider if your asthma does not get better or if it gets worse after you start treatment with TEZSPIRE. Treatment for severe asthma that is not limited to a specific type. These reprints may include some information about TEZSPIRE that is not contained in its FDA-approved Prescribing Information.

With common pathways and underlying disease drivers across respiratory and immunology, AstraZeneca is following the science from chronic lung diseases to immunology-driven disease areas. The Company’s growing presence in immunology is focused on five mid- to late-stage franchises with multi-disease potential, in areas including rheumatology , dermatology, gastroenterology, and systemic eosinophilic-driven diseases. AstraZeneca’s ambition in Respiratory & Immunology is to achieve disease modification and durable remission for millions of patients worldwide. Hypersensitivity reactions (e.g., rash and allergic conjunctivitis) can occur following administration of TEZSPIRE. These reactions can occur within hours of administration, but in some instances have a delayed onset (i.e., days). In the event of a hypersensitivity reaction, initiate appropriate treatment as clinically indicated and then consider the benefits and risks for the individual patient to determine whether to continue or discontinue treatment with TEZSPIRE.

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