Inebilizumab-cdon

First and Only CD19-Targeted Therapy Approved in Europe for Adults with anti-AChR+ and anti-MuSK+ gMG UPLIZNA Demonstrates Durable Disease Control with Twice-Yearly Dosing* THOUSAND OAKS, Calif., Feb. 12, 2026 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced the European Commission (EC) has approved UPLIZNA® (inebilizumab) as an add-on treatment to standard therapy for adults living with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) or anti-muscle specific tyrosine kinase (MuSK) antibody positive. The approval offers patients a new, targeted treatment option with the potential for long-term disease control through twice-yearly maintenance dosing, following two initial loading doses. Generalized myasthenia gravis is a rare, unpredictable, chronic, B-cell-mediated autoimmune disease that causes fluctuating muscle weakness and can impact quality of life.1-3 It is a subtype of myasthenia gravis (MG), which affects an estimated 56,000-123,000 people in Europe.4 "This approval represents an important advancement for adults with gMG in Europe, helping address debilitating symptoms and potentially reduce the long-term use of steroids where clinically appropriate," said Cesar Sanz Rodriguez, vice president of Medical Affairs at Amgen. "With convenient twice-yearly dosing and durable efficacy in people with anti‑AChR and anti‑MuSK antibody positive gMG, UPLIZNA brings a new first-in-class approach to managing this complex disease." The EC approval is supported by data from the Myasthenia Gravis Inebilizumab Trial (MINT), the largest Phase 3 biologic study to include both AChR+ and MuSK+ patients, and the first to successfully incorporate a structured steroid-tapering protocol. Patients receiving steroids at baseline began tapering at Week 4 with a goal of reaching prednisone 5 mg per day by Week 24. By Week 26, 87.4% of patients taking UPLIZNA and 84.6% of those taking placebo had reduced their steroid dose to 5 mg or less per day.5 "UPLIZNA offers a new approach to treating gMG by selectively targeting CD19-positive B cells, which play a key role in disease pathology," said John Vissing, MD, DMSci, professor of neurology and director of the Copenhagen Neuromuscular Center, Rigshospitalet, at the University of Copenhagen. "The approval provides both clinicians and patients a valuable new treatment option with the potential for long-term efficacy while addressing the challenges of long-term steroid exposure." The approval in gMG builds on UPLIZNA's established efficacy in rare autoimmune conditions, including its November 2025 EC approval as the first and only treatment for adults living with active immunoglobulin G4-related disease (IgG4-RD),6 a chronic and debilitating immune-mediated inflammatory condition that can affect multiple organs.7,8 UPLIZNA was also previously approved as a monotherapy for adult patients with neuromyelitis optica spectrum disorder (NMOSD) who are anti-aquaporin-4 immunoglobulin G (AQP4-IgG) seropositive.6 UPLIZNA has received regulatory approvals across multiple indications from the U.S. Food and Drug Administration, Health Canada, and the Brazilian Health Regulatory Agency (ANVISA), among others. About the MINT Trial MINT is a randomized, double-blind, placebo-controlled, parallel-group trial (NCT04524273) designed to evaluate the efficacy and safety of UPLIZNA in adults with gMG. The trial enrolled 238 adults with gMG, including 190 patients who are AChR+ and 48 patients who are MuSK+.5 Eligibility criteria at screening and randomization included a Myasthenia Gravis Foundation of America (MGFA) classification of II, III or IV disease, MG-ADL score between 6 and 10 with greater than 50% of this score attributed to non-ocular items, or an MG-ADL score of at least 11, and a Quantitative Myasthenia Gravis (QMG) score of at least 11.5 Participants had to have been receiving a stable dose of steroids and/or nonsteroidal immunosuppressive therapy (or both) at the time of randomization.5 The primary endpoint was change from baseline in MG-ADL score at Week 26 in the combined study population.5 Key secondary endpoints included change from baseline in QMG scores in the combined study population; change from baseline in MG-ADL score at Week 26 for the AChR+ cohort and separately the MuSK+ cohort; and change from baseline in QMG score at Week 26 for the AChR+ cohort and separately the MuSK+ cohort.5 MINT also includes an optional three-year open-label treatment period. Key findings from MINT include5: Primary Endpoint: A 1.9-point difference in the MG-ADL score for UPLIZNA (-4.2) compared to placebo (-2.2) (p<0.0001) at Week 26 for the combined study population. Key Secondary Endpoints: A 2.5-point difference in the QMG score for UPLIZNA (-4.8) compared to placebo (-2.3) (p=0.0002) at Week 26 for the combined treated population. A 1.8-point difference in the MG-ADL score for UPLIZNA (-4.2) compared to placebo (-2.4) (p=0.0015) at Week 26 for the AChR+ population. A 2.5-point difference in the QMG score for UPLIZNA (-4.4) compared to placebo (-2.0) (p=0.0011) at Week 26 for the AChR+ population. A 2.2-point difference in the MG-ADL score for UPLIZNA (-3.9) compared to placebo (-1.7) (p=0.0297) at Week 26 for the MuSK+ population. A 2.3-point difference in the QMG score for UPLIZNA (-5.2) compared to placebo (-3.0) (p=0.1326) at Week 26 for the MuSK+ population; this difference was not statistically significant. Additional Exploratory Endpoints: A 2.8-point difference (95% CI: −3.9 to −1.7) in the MG-ADL score for UPLIZNA (-4.7) compared with placebo (-1.9) at Week 52 for the AChR+ population. A 4.3-point difference (95% CI: −5.9 to −2.8) in the QMG score for UPLIZNA (-5.8) compared with placebo (-1.4) at Week 52 for the AChR+ population. 87.4% of UPLIZNA patients and 84.6% of those taking placebo reduced their steroid dose to 5 mg or less per day by Week 26. MG-ADL scale, which assesses the impact of gMG on daily functions of 8 signs or symptoms that are typically affected in gMG. Each item is assessed on a 4-point scale, where a score of 0 represents normal function and a score of 3 represents loss of ability to perform that function. The total MG-ADL score ranges from 0 to 24, with higher scores indicating more impairment. The QMG score is a 13-item categorical grading system that quantitively measures disease impairment by mainly assessing muscle weakness. Each item is assessed on a 4-point scale where a score of 0 represents no impairment weakness and a score of 3 represents severe impairment weakness. A total possible score ranges from 0 to 39, where higher scores indicate more severe impairment. About Generalized Myasthenia Gravis (gMG) Generalized myasthenia gravis (gMG) is a rare, chronic, B-cell-mediated autoimmune disorder that impairs neuromuscular communication and can cause muscle weakness, trouble breathing, difficulty swallowing and impaired speech and vision.1-3 Approximately 85% of patients with myasthenia gravis have the generalized form, or gMG.9,10 The prevalence and incidence of gMG are increasing worldwide.10 There are an estimated 56,000 to 123,000 people with myasthenia gravis in Europe, with prevalence rates in different countries varying significantly.4 Approximately 85% of patients with myasthenia gravis have detectable antibodies against AChR, and approximately 7% have detectable antibodies against MuSK.11 Global prevalence is estimated at 2-36 cases per 100,000.4 The disease is more frequently seen in young women (age 20-30) and men aged 50 years and older.4,10 B cells are central to the pathogenesis of gMG. The disease is thought to be primarily driven by pathogenic CD19+ plasmablasts and plasma cells that target critical proteins in the neuromuscular junction.1-3 About UPLIZNA® (inebilizumab) UPLIZNA is a humanized monoclonal antibody (mAb) that causes targeted and sustained depletion of key cells that contribute to the underlying disease process (autoantibody-producing CD19+ B cells, including plasmablasts and some plasma cells). The precise mechanism by which UPLIZNA exerts its therapeutic effects is unknown. After two initial infusions, patients need one maintenance dose of UPLIZNA every six months. 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, heart disease, inflammatory conditions, rare diseases 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. 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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. CONTACT: Amgen, Thousand Oaks Elissa Snook, 609-251-1407 (media) Annik Allen, 917-288-9136 (media) Casey Capparelli, 805-447-1746 (investors) References *After two initial loading doses. Yi JS, Guptill JT, Stathopoulos P, Nowak RJ, O'Connor KC. B cells in the pathophysiology of myasthenia gravis. Muscle Nerve. 2018;57(2):172-184. Willcox HN, Newsom-Davis J, Calder LR. Cell types required for anti-acetylcholine receptor antibody synthesis by cultured thymocytes and blood lymphocytes in myasthenia gravis. Clin Exp Immunol. 1984;58:97-106. Stathopoulos P, Kumar A, Nowak RJ, O'Connor KC. Autoantibody-producing plasmablasts after B cell depletion identified in muscle-specific kinase myasthenia gravis. JCI Insight. 2017;2(17):e94263. Bubuioc AM, Kudebayeva A, Turuspekova S, Lisnic V, Leone MA. The epidemiology of myasthenia gravis. J Med Life. 2021;14(1):7-16. Nowak R, Benatar M, Ciafaloni E, et al. A phase 3 trial of inebilizumab in generalized myasthenia gravis. N Engl J Med. 2025;392(23):2309-2320. European Medicines Agency. First treatment recommended for rare immunoglobulin-related autoimmune disease. Available at: . Accessed: February 2026. Stone JH, Khosroshahi A, Zhang W, et al. Inebilizumab for Treatment of IgG4-Related Disease. N Engl J Med. 2025;392(12):1168-1177. Perugino CA, Stone JH. IgG4-related disease: an update on pathophysiology and implications for clinical care. Nat Rev Rheumatol. 2020;16(12):702-714. Lazaridis K, Tzartos SJ. Autoantibody specificities in myasthenia gravis: implications for improved diagnostics and therapeutics. Front Immunol. 2020;11:212. Dresser L, Wlodarski R, Rezania K, Soliven B. Myasthenia gravis: epidemiology, pathophysiology and clinical manifestations. J Clin Med. 2021;10(11):2235. Hehir MK, Silvestri NJ. Generalized myasthenia gravis: classification, clinical presentation, natural history, and epidemiology. Neurol Clin. 2018;36:253-260. Logo - 21% more press release views with Request a Demo

Amgen has opposed a request by the FDA to voluntarily withdraw its rare disease drug Tavneos from the market. The agency is questioning the integrity of data from a 2021 trial conducted by Amgen subsidiary ChemoCentryx. Amgen has denied a request by the FDA to voluntarily withdraw its rare disease drug Tavneos from the market, the company said Tuesday as it presented quarterly financial results.Amgen explained that the U.S. regulator issued its request Jan. 16 and that, “following FDA regulatory process,” the company informed the agency Jan. 28 of its intention to keep the drug on the market. The California drugmaker added that it is evaluating next steps with the agency to “determine a path forward.”The news comes days after the European Medicines Agency said it was re-reviewing Tavneos because of concerns about the integrity of the data in the drug’s pivotal trial.Last month, FDA told Amgen that it was questioning the process followed by the original developer of the drug, ChemoCentryx, to re-adjudicate primary endpoint results for nine of the 331 patients in its phase 3 study. The FDA also is reviewing the risk-benefit profile of Tavneos, which can, in rare cases, cause hepatotoxicity, Amgen added.“Amgen is not aware of any issue with the underlying patient data from the ChemoCentryx clinical trial,” the company wrote in its fourth-quarter earnings release. "And after review of the relevant clinical data and years of real-world evidence, Amgen is confident that Tavneos demonstrates effectiveness and a favorable benefit–risk profile."Amgen’s commercial operations chief Murdo Gordon emphasized during a conference call that there are “limited therapeutic options” for patients on Tavneos, which treats antineutrophil cytoplasmic antibody-associated vasculitis, which causes inflammation of the blood vessels.The company offered little else on Tavneos during its presentation and call.“We’re in discussions with the FDA, and we’ll answer questions as we talk with them,” Jay Bradner, Amgen’s R&D chief, said Tuesday. Tavneos was approved in the U.S. in 2021, and Europe signed off on the complement inhibitor in 2022. That same year, Amgen bought out ChemoCentryx for $3.7 billion.Concerns about the trial have been mounting since 2021, when the FDA flagged them ahead of a preapproval advisory committee meeting. Even though Tavneos eventually got its FDA nod—with a narrower label than anticipated—investors filed a lawsuit in 2022 alleging that ChemoCentryx knew about the FDA’s concerns but downplayed them.As the legal feud progressed, additional evidence emerged last year pointing to a larger data integrity issue in the trial. Despite this, Amgen was victorious defending itself in a lawsuit that was dismissed six months ago as a California judge agreed with the company’s argument that the FDA’s approval of a drug “precludes a securities fraud plaintiff from showing that a defendant’s favorable interpretation of the drug’s clinical trial data was fraudulent.”Amgen has one of the most diverse and deep portfolios in the industry, counting 14 blockbuster drugs in 2025. And, even though CEO Bob Bradway called Tavneos “a very small product in our portfolio relative to the other things we’ve got going on,” losing it would be blow as its sales are scaling up rapidly. In 2025, Tavneos generated $459 million, which was a 62% year-over-year increase, “driven by strong volume growth,” according to Gordon.Amgen was much more anxious to discuss the trajectory of another of its rare disease treatments, Uplizna, which gained two label expansions in 2025. One is to treat certain patients with generalized myasthenia gravis (gMG); the other was for those with immunoglobulin G4-related disease (IgG4-RD). The company estimated Tuesday that the U.S. patient population in the new IgG4-RD indication is 35,000, with potential to grow. Amgen also said it expects this year to kick off two phase 3 trials of Uplizna—one for patients with autoimmune hepatitis and another for those with chronic inflammatory demyelinating polyneuropathy.Uplizna sales were up 73% in 2025 to $655 million, “reflecting growing patient demand across all three approved indications,” Gordon said. The drug hit the market in 2020 as a treatment for original neuromyelitis optica spectrum disorder.“Uplizna’s unique anti-CD19 (mechanism of action), which provides efficacy and dosing advantages vs. [FcRn inhibitors], plays into a gMG market that is currently evenly split between biologics-naïve and switchers,” analysts from Citi wrote. Amgen’s overall revenue came in at $36.7 billion in 2025, which was an increase of 10%. The company is guiding to a smaller revenue increase in 2026, pegging sales at between $37 billion and $38.4 billion, with Chief Financial Officer Peter Griffith calling it a “springboard year for future growth” as the company rides out biosimilar competition for denosumab (osteoporosis treatments Prolia and Xgeva).“[Amgen’s] rare disease, oncology, and biosimilars portfolios could also help offset further acceleration of  denosumab erosion on deck for this year,” Citi wrote, estimating a 30% year-over-year decline in sales of Prolia and Xgeva. “Specifically, Uplizna might be an underappreciated asset within the Horizon portfolio.”