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New Phase 3 MITIGATE Open-Label Extension Data Support the Long-Term Safety Profile and Sustained Results of UPLIZNA® in IgG4-RD
Real-World Evidence Supports TAVNEOS® Efficacy and Safety Profile with Reduced Steroid Use in ANCA-Associated Vasculitis
THOUSAND OAKS, Calif., June 3, 2026 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced the presentation of new data across rare autoimmune and inflammatory diseases at the European Alliance of Associations for Rheumatology (EULAR) 2026 Congress, taking place from June 3-6 in London.
New data from the Phase 3 MITIGATE trial of UPLIZNA® (inebilizumab) provide insights into the biology of immunoglobulin G4-related disease (IgG4-RD),1 while additional analyses support its long-term safety profile and sustained results in IgG4-RD.2 Additionally, new real-world evidence on TAVNEOS® (avacopan) further support its established efficacy and safety profile with reduced steroid use in people living with anti-neutrophil cytoplasmic antibodies (ANCA)-associated vasculitis.3
"Patients living with rare autoimmune diseases still face significant unmet medical needs despite advances in treatment, with conditions often being difficult to diagnose and challenging to manage," said Paul Burton, M.D., Ph.D., chief medical officer at Amgen. "The data we're presenting at EULAR deepen our understanding of disease biology and demonstrate the strength of our portfolio of options for patients with these conditions, reflecting our commitment to advancing the science and delivering meaningful progress for patients."
Key presentations include:
Long-term Efficacy and Safety of Inebilizumab in IgG4-Related Disease: Primary Results from Year 1 of the Open-Label Period (OLP) of the Phase 3 MITIGATE Trial
Abstract #POS0440, Poster View 1 (Poster View Presentation), Wednesday, June 3 from 3:30–4:30 p.m. BST
IgG4-RD is a chronic and debilitating condition, marked by recurrent, unpredictable flares that can potentially impact multiple organs.4,5 New Phase 3 MITIGATE data further support the longer-term clinical profile of UPLIZNA.
Key findings include:
"For clinicians, a sustained reduction in flares and timely intervention are central to improving long-term outcomes," said John Stone, M.D., M.P.H., principal investigator and a professor of medicine at Harvard Medical School and the Edward A. Fox Chair in Medicine at the Massachusetts General Hospital. "The new MITIGATE data reinforce the long-term safety and efficacy profile of UPLIZNA while advancing our understanding of how IgG4-RD progresses over time. These findings may help clinicians identify opportunities for earlier intervention and reduce avoidable flares."
Natural History of IgG4-RD: Patterns of Organ Involvement and Flare-associated Biomarker Changes in the Phase 3 MITIGATE Trial
Abstract #OP052, Basic and Clinical Abstract Sessions: Insights in Other Diseases (Oral Abstract Presentation), Wednesday, June 3 from 4:30–4:40 p.m. BST
The first-of-its-kind natural history analysis reinforced the chronic and unpredictable nature of IgG4-RD, underscoring widespread and diverse multi-organ involvement and the need for earlier intervention and more comprehensive monitoring and risk stratification.
Key findings include:
An additional exploratory combined analysis (Abstract #POS0089) of clinical trial RCP and OLP data in MITIGATE (N=119) showed how long-term use of UPLIZNA resulted in mostly mild immunoglobulin (Ig) reduction, with no significant association between these Ig reductions and occurrence of infections or serious infections. The incidence of infections and serious infections did not increase with each additional year of UPLIZNA treatment.
Real-World Evidence Supports TAVNEOS Efficacy, Safety and Reduced Steroid Use
The AQUARIUS analyses (Abstracts #POS01356 and #POS08673), conducted at Massachusetts General Hospital and Northwestern University, evaluated the largest U.S. real-world cohort to date of patients with granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA) treated with TAVNEOS (n=159). The findings provide new insights into clinical outcomes in patients with ANCA-associated vasculitis and are consistent with the established clinical efficacy and safety profile of TAVNEOS in patients with severe active GPA or MPA.3,6
"Real-world experience with TAVNEOS across two large healthcare systems demonstrates that many patients can achieve meaningful disease control with reduced reliance on glucocorticoids when considering prior standard-of-care glucocorticoid regimens," said Naomi Patel, M.D., rheumatologist at Massachusetts General Hospital and study investigator. "Because prolonged steroid use carries significant risks for patients, these findings are encouraging and also suggest that shorter steroid tapers (e.g., < 2 months) may reduce overall glucocorticoid exposure without compromising effectiveness outcomes."
Key findings include:
"People living with ANCA-associated vasculitis often have limited treatment options and may rely heavily on steroids for disease control," said Joyce Kullman, executive director, Vasculitis Foundation. "Given the challenges associated with long-term steroid use, these new data reinforce that TAVNEOS can help patients achieve disease control with reduced steroid use. For the vasculitis community, this may represent a step toward reducing treatment burden over time."
For more information on the full list of Amgen abstracts and presentation times, see below.
All Amgen-sponsored abstracts being presented at EULAR:
UPLIZNA® (inebilizumab)
TAVNEOS (avacopan)
KRYSTEXXA (pegloticase)
OTEZLA (apremilast)
Partner-Led Abstracts
About UPLIZNA® (inebilizumab)
UPLIZNA is a humanized monoclonal antibody (mAb) that causes targeted and sustained depletion of key cells that contribute to underlying disease process (autoantibody-producing CD19+ B cells, including plasmablasts and some plasma cells). The precise mechanism by which UPLIZNA exerts its therapeutic effects in IgG4-RD is unknown. After two initial infusions, patients need one dose of UPLIZNA every six months.7
About TAVNEOS® (avacopan)
TAVNEOS is an orally administered small molecule indicated as an adjunctive treatment for adult patients with severe active ANCA-associated vasculitis (GPA/MPA). It is a selective complement 5a receptor (C5aR) antagonist that targets inflammation by blocking the activity of C5a, a key driver of neutrophil activation. By inhibiting C5aR, TAVNEOS helps reduce inflammation while preserving other complement system functions. The precise mechanism by which TAVNEOS exerts its therapeutic effects in ANCA-associated vasculitis has not been fully established.8
UPLIZNA® (inebilizumab-cdon) U.S. INDICATIONS
UPLIZNA® (inebilizumab-cdon) is indicated in adult patients for the treatment of: anti-aquaporin-4 (AQP4) antibody positive neuromyelitis optica spectrum disorder (NMOSD); Immunoglobulin G4-related disease (IgG4-RD); anti-acetylcholine receptor (AChR) or anti-muscle specific tyrosine kinase (MuSK) antibody positive (Ab+) generalized myasthenia gravis (gMG).
UPLIZNA U.S. IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS
UPLIZNA® (inebilizumab-cdon) is contraindicated in patients with a history of a life-threatening infusion reaction to UPLIZNA, active hepatitis B infection, or active or untreated latent tuberculosis.
WARNINGS AND PRECAUTIONS
ADVERSE REACTIONS
Please see UPLIZNA® full Prescribing Information
TAVNEOS (avacopan) U.S. INDICATION
TAVNEOS (avacopan) is indicated as an adjunctive treatment of adult patients with severe active anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis (granulomatosis with polyangiitis [GPA] and microscopic polyangiitis [MPA]) in combination with standard therapy including glucocorticoids. TAVNEOS does not eliminate glucocorticoid use.
TAVNEOS U.S. IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS
Serious hypersensitivity to avacopan or to any of the excipients.
WARNINGS AND PRECAUTIONS
ADVERSE REACTIONS
DRUG INTERACTIONS
Please see Full Prescribing Information and Medication Guide for TAVNEOS.
To report a suspected adverse event, call 1-833-828-6367. You may report to the FDA directly by visiting www.fda.gov/medwatch or calling 1-800-332-1088.
About Amgen
Amgen discovers, develops, manufactures and delivers innovative medicines to fight some of the world's toughest diseases. Harnessing the best of biology and technology, Amgen reaches millions of patients with its medicines.
More than 45 years ago, Amgen helped establish the biotechnology industry at its U.S. headquarters in Thousand Oaks, California, and it remains at the cutting edge of innovation, using technology and human genetic data to push beyond what is known today. Amgen is advancing a broad and deep pipeline and portfolio of medicines to treat cancer, inflammatory conditions, rare diseases, heart disease and obesity and obesity-related conditions.
Amgen has been consistently recognized for innovation and workplace culture, including honors from Fast Company and Forbes. Amgen is one of the 30 companies that comprise the Dow Jones Industrial Average® and it is also part of the Nasdaq-100 Index®, which includes the largest and most innovative non-financial companies listed on the Nasdaq Stock Market based on market capitalization.
For more information, visit Amgen.com and follow Amgen on X, LinkedIn, Instagram, YouTube, Facebook, TikTok and Threads.
Amgen Forward-Looking Statements
This news release contains forward-looking statements that are based on the current expectations and beliefs of Amgen. All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including any statements on the outcome, benefits and synergies of collaborations, or potential collaborations, with any other company (including BeOne Medicines Ltd.), the performance of Otezla® (apremilast), our acquisitions of ChemoCentryx, Inc., Dark Blue Therapeutics, Ltd. or Horizon Therapeutics plc (including the prospective performance and outlook of Horizon's business, performance and opportunities, and any potential strategic benefits, synergies or opportunities expected as a result of such acquisition), as well as estimates of revenues, operating margins, capital expenditures, cash, other financial metrics, expected legal, arbitration, political, regulatory or clinical results or practices, customer and prescriber patterns or practices, reimbursement activities and outcomes, effects of pandemics or other widespread health problems on our business, outcomes, progress, and other such estimates and results. Forward-looking statements involve significant risks and uncertainties, including those discussed below and more fully described in the Securities and Exchange Commission reports filed by Amgen, including our most recent annual report on Form 10-K and any subsequent periodic reports on Form 10-Q and current reports on Form 8-K. Unless otherwise noted, Amgen is providing this information as of the date of this news release and does not undertake any obligation to update any forward-looking statements contained in this document as a result of new information, future events or otherwise.
No forward-looking statement can be guaranteed and actual results may differ materially from those we project. 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 us to complete clinical trials and obtain regulatory approval for product marketing has in the past varied and we expect similar variability in the future. Even when clinical trials are successful, regulatory authorities may question the sufficiency for approval of the trial endpoints we have selected. We develop 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 we may have believed at the time of entering into such relationship. Also, we or others could identify safety, side effects or manufacturing problems with our products, including our devices, after they are on the market.
Our results may be affected by our 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 our products and global economic conditions, including those resulting from geopolitical relations and government actions. In addition, sales of our 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, our research, testing, pricing, marketing and other operations are subject to extensive regulation by domestic and foreign government regulatory authorities. Our business may be impacted by government investigations, litigation and product liability claims. In addition, our business may be impacted by the adoption of new tax legislation or exposure to additional tax liabilities. Further, while we routinely obtain patents for our products and technology, the protection offered by our patents and patent applications may be challenged, invalidated or circumvented by our competitors, or we may fail to prevail in present and future intellectual property litigation. We perform a substantial amount of our commercial manufacturing activities at a few key facilities, including in Puerto Rico, and also depend on third parties for a portion of our manufacturing activities, and limits on supply may constrain sales of certain of our current products and product candidate development. An outbreak of disease or similar public health threat, 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 our manufacturing activities, the distribution of our products, the commercialization of our product candidates, and our clinical trial operations, and any such events may have a material adverse effect on our product development, product sales, business and results of operations. 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, and may result in unanticipated costs, delays or failures to realize the benefits of the transactions. A breakdown, cyberattack or information security breach of our information technology systems 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. Our business and operations may be negatively affected by the failure, or perceived failure, of achieving our sustainability objectives. The effects of global climate change and related natural disasters could negatively affect our business and operations. 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.
The scientific information discussed in this news release related to our product candidates is preliminary and investigative. Such product candidates are not approved by the U.S. Food and Drug Administration, and no conclusions can or should be drawn regarding the safety or effectiveness of the product candidates. Further, any scientific information discussed in this news release relating to new indications for our products is preliminary and investigative and is not part of the labeling approved by the U.S. Food and Drug Administration for the products. The products are not approved for the investigational use(s) discussed in this news release, and no conclusions can or should be drawn regarding the safety or effectiveness of the products for these uses.
CONTACT: Amgen, Thousand Oaks
Elissa Snook, 609-251-1407 (media)
Annik Allen, 917-288-9136 (media)
Casey Capparelli, 805-447-1746 (investors)
References
SOURCE Amgen

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