TEZSPIRE® APPROVED FOR SELF-ADMINISTRATION IN THE U.S. WITH A NEW PRE-FILLED PEN
Now Offers Patients the Choice of Administration at Home or in a Doctor's Office
THOUSAND OAKS, Calif., Feb. 2, 2023 /PRNewswire/ -- Amgen (NASDAQ:AMGN) and AstraZeneca Pharmaceuticals LP today announced the U.S. Food and Drug Administration (FDA) has approved TEZSPIRE® (tezepelumab-ekko) for self-administration in a pre-filled, single-use pen for patients aged 12 years and older with severe asthma.1 First approved by the FDA in December 2021, TEZSPIRE is the only biologic approved for severe asthma with no phenotype (e.g., eosinophilic or allergic) or biomarker limitation within its approved label.2-9
"People with severe asthma will now have the flexibility to administer TEZSPIRE at home or continue to receive their medicine in their doctor's office," said Murdo Gordon, executive vice president of Global Commercial Operations at Amgen. "This approval reinforces our continued efforts to improve accessibility to TEZSPIRE, a first-in-class medicine proven to consistently and significantly reduce exacerbations across a broad population of people with severe asthma."
The approval by the FDA was based on results from the PATHFINDER clinical trial program, which included results from the PATH-BRIDGE Phase 1 trial and the PATH-HOME trial Phase 3 trial.10 The majority (92%) of healthcare providers, patients and caregivers were able to successfully administer TEZSPIRE both in the clinic and at home throughout the PATH-HOME trial. The improvements in asthma control and the safety profile of TEZSPIRE observed in the PATH-HOME trial were consistent with previous clinical trials.10
"Severe asthma continues to be a very complex condition to manage, so we welcome the TEZSPIRE pre-filled pen as an option that will empower patients and healthcare providers with increased choice," said Kenneth Mendez, president and chief executive officer of the Asthma and Allergy Foundation of America. "We believe self-administration alternatives can play an important role in patients' lives and address unmet needs for those living with severe asthma."
The most common adverse reactions (incidence ≥3% and more common than placebo) of TEZSPIRE are pharyngitis, arthralgia, and back pain.1
TEZSPIRE self-administration and the TEZSPIRE pre-filled pen are also approved in the European Union (EU) and are under regulatory review in several other countries around the world. TEZSPIRE is currently approved for the treatment of severe asthma in the U.S., EU, Japan and other countries.
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 full Prescribing Information including Patient Information and Instructions for Use.
You may report side effects related to AstraZeneca products by clicking here.
About TEZSPIRE® (tezepelumab-ekko)
Expression of TSLP is increased in the airways of patients with asthma and has been correlated with disease severity.11,13 Blocking TSLP may prevent the release of pro-inflammatory cytokines by immune cells, resulting in the prevention of asthma exacerbations and improved asthma control.11,13 By working at the top of the cascade, TEZSPIRE helps stop inflammation at the source and has the potential to treat a broad population of severe asthma patients.11,13
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.22-24 Eosinophilic asthma, and more broadly, T2 inflammation-driven asthma, accounts for about two-thirds of patients with severe asthma.24 These patients are typically characterized as having elevated levels of inflammatory biomarkers, including blood eosinophils, serum IgE and FeNO.25,26 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.26
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 2022, Amgen was named one of the "World's Best Employers" by Forbes and one of "America's 100 Most Sustainable Companies" by Barron's.
For more information, visit Amgen.com and follow us on Twitter, LinkedIn, Instagram, TikTok and YouTube.
Amgen Forward-Looking Statements
No forward-looking statement can be guaranteed and actual results may differ materially from those Amgen projects. Discovery or identification of new product candidates or development of new indications for existing products cannot be guaranteed and movement from concept to product is uncertain; consequently, there can be no guarantee that any particular product candidate or development of a new indication for an existing product will be successful and become a commercial product. Further, preclinical results do not guarantee safe and effective performance of product candidates in humans. The complexity of the human body cannot be perfectly, or sometimes, even adequately modeled by computer or cell culture systems or animal models. The length of time that it takes for Amgen to complete clinical trials and obtain regulatory approval for product marketing has in the past varied and Amgen expects similar variability in the future. Even when clinical trials are successful, regulatory authorities may question the sufficiency for approval of the trial endpoints Amgen has selected. Amgen develops product candidates internally and through licensing collaborations, partnerships and joint ventures. Product candidates that are derived from relationships may be subject to disputes between the parties or may prove to be not as effective or as safe as Amgen may have believed at the time of entering into such relationship. Also, Amgen or others could identify safety, side effects or manufacturing problems with its products, including its devices, after they are on the market.
Amgen's results may be affected by its ability to successfully market both new and existing products domestically and internationally, clinical and regulatory developments involving current and future products, sales growth of recently launched products, competition from other products including biosimilars, difficulties or delays in manufacturing its products and global economic conditions. In addition, sales of Amgen's products are affected by pricing pressure, political and public scrutiny and reimbursement policies imposed by third-party payers, including governments, private insurance plans and managed care providers and may be affected by regulatory, clinical and guideline developments and domestic and international trends toward managed care and healthcare cost containment. Furthermore, Amgen's research, testing, pricing, marketing and other operations are subject to extensive regulation by domestic and foreign government regulatory authorities. Amgen's business may be impacted by government investigations, litigation and product liability claims. In addition, Amgen's business may be impacted by the adoption of new tax legislation or exposure to additional tax liabilities. If Amgen fails to meet the compliance obligations in the corporate integrity agreement between Amgen and the U.S. government, Amgen could become subject to significant sanctions. Further, while Amgen routinely obtains patents for its products and technology, the protection offered by its patents and patent applications may be challenged, invalidated or circumvented by its competitors, or Amgen may fail to prevail in present and future intellectual property litigation. Amgen performs a substantial amount of its commercial manufacturing activities at a few key facilities, including in Puerto Rico, and also depends on third parties for a portion of its manufacturing activities, and limits on supply may constrain sales of certain of its current products and product candidate development. An outbreak of disease or similar public health threat, such as COVID-19, and the public and governmental effort to mitigate against the spread of such disease, could have a significant adverse effect on the supply of materials for Amgen's manufacturing activities, the distribution of Amgen's products, the commercialization of Amgen's product candidates, and Amgen's clinical trial operations, and any such events may have a material adverse effect on Amgen's product development, product sales, business and results of operations. Amgen relies on collaborations with third parties for the development of some of its product candidates and for the commercialization and sales of some of its commercial products. In addition, Amgen competes with other companies with respect to many of its marketed products as well as for the discovery and development of new products. Further, some raw materials, medical devices and component parts for Amgen's products are supplied by sole third-party suppliers. Certain of Amgen's distributors, customers and payers have substantial purchasing leverage in their dealings with Amgen. The discovery of significant problems with a product similar to one of Amgen's products that implicate an entire class of products could have a material adverse effect on sales of the affected products and on its business and results of operations. Amgen's 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 Amgen has acquired, may not be successful. A breakdown, cyberattack or information security breach could compromise the confidentiality, integrity and availability of Amgen's systems and Amgen's data. Amgen's stock price may be volatile and may be affected by a number of events. Amgen's business and operations may be negatively affected by the failure, or perceived failure, of achieving its environmental, social and governance objectives. The effects of global climate change and related natural disasters could negatively affect Amgen's business and operations. Global economic conditions may magnify certain risks that affect Amgen's business. Amgen's business performance could affect or limit the ability of the Amgen Board of Directors to declare a dividend or its ability to pay a dividend or repurchase its common stock. Amgen may not be able to access the capital and credit markets on terms that are favorable to it, or at all.
CONTACT: Amgen, Thousand Oaks
View original content to download multimedia:https://www.prnewswire.com/news-releases/tezspire-approved-for-self-administration-in-the-us-with-a-new-pre-filled-pen-301736900.html
Company Codes: NASDAQ-NMS:AMGN