AMGEN TO PRESENT DATA AT ACR 2023 ACROSS EXPANDED RHEUMATOLOGY PIPELINE AND PORTFOLIO Breadth of Research Reflects Amgen's Commitment to Rheumatology THOUSAND OAKS, Calif., Nov. 1, 2023 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced the presentation of new scientific and clinical research across its expanded rheumatology pipeline and portfolio, following the recent acquisition of Horizon Therapeutics. More than 20 abstracts will be presented during the American College of Rheumatology (ACR) Convergence 2023, taking place Nov. 10-15, in San Diego. "The data at ACR will illustrate our continued growth in rheumatology as we advance unique treatment approaches across a broader range of diseases," said David M. Reese, M.D., executive vice president of Research and Development at Amgen. "Drawing on our decades of experience in inflammation, we're looking forward to advancing new treatment areas like Sjögren's syndrome and uncontrolled gout." Abstracts and Presentation Times:
Amgen Sponsored Abstracts Pharmacokinetic and Safety Similarity of High- and Low-Concentration Formulations of Adalimumab Biosimilar ABP 501
Abstract #2161, Poster Session C: RA – Treatments Poster III, Tuesday, Nov. 14 from 9-11am PST
Abstract #0441, Poster Session A: RA – Treatments Poster I, Sunday, Nov. 12 from 9-11am PST
Treatment-Emergent Major Adverse Cardiovascular and Thromboembolic Events Were Infrequent During Pegloticase Therapy: Pooled Clinical Trial Findings Abstract #0236, Poster Session A: Metabolic & Crystal Arthropathies – Basic & Clinical Science Poster I, Sunday, Nov. 12 from 9-11am PST
Oral Urate-Lowering Therapy Use and Efficacy Following Pegloticase Treatment: Findings from a Rheumatology Network Database Abstract #0237, Poster Session A: Metabolic & Crystal Arthropathies – Basic & Clinical Science Poster I, Sunday, Nov. 12 from 9-11am PST
Abstract #0239, Poster Session A: Metabolic & Crystal Arthropathies – Basic & Clinical Science Poster I, Sunday, Nov. 12 from 9-11am PST
Abstract #0242, Poster Session A: Metabolic & Crystal Arthropathies – Basic & Clinical Science Poster I, Sunday, Nov. 12 from 9-11am PST
Finding Lost-to-Care Gout Patients in a Large Community Rheumatology Network: Patient Re-engagement Initiative with Metrics (PRIME) Abstract #1102, Poster Session B: Metabolic & Crystal Arthropathies – Basic & Clinical Science Poster II, Monday, Nov. 13 from 9-11am PST
Evaluation of Outcomes Following Discontinuation of Pegloticase Therapy Abstract #1103, Poster Session B: Metabolic & Crystal Arthropathies – Basic & Clinical Science Poster II, Monday, Nov. 13 from 9-11am PST
Abstract #1107, Poster Session B: Metabolic & Crystal Arthropathies – Basic & Clinical Science Poster II, Monday, Nov. 13 from 9-11am PST
Minimal Clinically Important Difference (MCID) of Quality of Life Assessments in Patients with Uncontrolled Gout Abstract #1108, Poster Session B: Metabolic & Crystal Arthropathies – Basic & Clinical Science Poster II, Monday, Nov. 13 from 9-11am PST
Real-world Trends in the Use of Immunomodulation as Co-Therapy to Pegloticase: Claims-Based Findings Since 2016 Abstract #1123, Poster Session B: Metabolic & Crystal Arthropathies – Basic & Clinical Science Poster II, Monday, Nov. 13 from 9-11am PST
Understanding Community Perspectives on Disease Management: A Social Media Analysis of Gout Care Strategies Abstract #1204, Poster Session B: Patient Outcomes, Preferences, & Attitudes Poster II, Monday, Nov. 13 from 9-11am PST
Abstract #0966, Poster Session B: Epidemiology & Public Health Poster II, Monday Nov. 13 from 9-11am PST
Abstract #1041, Poster Session B: Imaging of Rheumatic Diseases Poster I, Monday Nov. 13 from 9-11am PST Current Trends in the Risk of Subsequent Fracture After Initial Fracture, and Post-Fracture Treatment Among Commercially Insured Postmenopausal Women in the United States Abstract #0857, Oral Abstract Session: Vasculitis – ANCA-Associated I, Sunday, Nov. 12 from 5-5:15pm PST Remission, Glucocorticoid Toxicity, Health-Related Quality of Life, and Safety Outcomes in Patients with Renal Involvement in the Phase 3 Trial of Avacopan for the Treatment of ANCA-Associated Vasculitis Abstract #0683, Poster Session A: Vasculitis – ANCA-Associated Poster I: Treatment Outcomes, Sunday, Nov. 12 from 9-11am PST Abstract #0684, Poster Session A: Vasculitis – ANCA-Associated Poster I: Treatment Outcomes, Sunday, Nov. 12 from 9-11am PST Abstract #0685, Poster Session A: Vasculitis – ANCA-Associated Poster I: Treatment Outcomes, Sunday, Nov. 12 from 9-11am PST Abstract #0686, Poster Session A: Vasculitis – ANCA-Associated Poster I: Treatment Outcomes, Sunday, Nov. 12 from 9-11am PST A Real-World Descriptive Study of Renal Outcomes Among Patients with ANCA-Associated Vasculitis Initiating Remission Induction Therapy Abstract #2379, Poster Session C: Vasculitis – ANCA-Associated Poster III: Biomarkers & Renal Outcomes, Tuesday, Nov. 14 from 9-11am PST Abstract #0171, Poster Session A: Health Services Research Poster I, Sunday, Nov. 12 from 9-11am PST
Dazodalibep, a CD40L Antagonist, in Subjects with Sjögren's Having Moderate-to-Severe Systemic Disease Activity: Full Crossover Results from a Phase 2, Randomized, Double-Blind, Placebo-Controlled, Proof of Concept Study Abstract #1636, Oral Abstract Session: Sjögren's Syndrome – Basic & Clinical Science, Monday, Nov. 13 from 2-3:30pm PST Dazodalibep, a CD40L Antagonist, in a Phase 2, Randomized, Double-Blind, Placebo-Controlled, Crossover Trial of Subjects with Sjögren's Disease Having Unacceptable Symptomatic Burden but Limited Extraglandular Organ Involvement Abstract #L10, Late-Breaking Abstract Posters: Poster Session C, Tuesday, Nov. 14 from 9-11 am PST
CD40L Inhibition with Dazodalibep Rapidly Reduces Blood Biomarkers of T and B Cell Costimulation in Subjects with Sjögren's Having High Disease Activity or High Symptom Burden Abstract #1638, Oral Abstract Session: Sjögren's Syndrome – Basic & Clinical Science, Monday, Nov. 13 from 2-3:30pm PST Treatment Patterns and Drivers of Biologic Prescriptions in Patients with Primary Sjögren's Disease: Results from a Multinational, Real-World Survey Abstract #1369, Poster Session B: Sjögren's Syndrome – Basic & Clinical Science Poster I, Monday, Nov. 13 from 9-11am PST Abstract #1379, Poster Session B: Sjögren's Syndrome – Basic & Clinical Science Poster I, Monday, Nov. 13 from 9-11am PST Abstract #2179, Poster Session C: Sjögren's Syndrome – Basic & Clinical Science Poster II, Tuesday, Nov. 14 from 9-11am PST Osteoporosis Treatment Attributes and Levels for an Online Decision-Making Tool for Patients: Findings from Adaptive Choice-Based Conjoint Analysis Abstract #2025, Poster Session C: Patient Outcomes, Preferences, & Attitudes Poster III, Tuesday, Nov. 14 from 9-11am PST
Efficacy and Safety Experience with Avacopan Beyond 52 Weeks in the Early Access Program (EAP) Abstract #0688, Poster Session A: Vasculitis – ANCA-Associated Poster I: Treatment Outcomes, Sunday, Nov. 12 from 9-11am PST KRYSTEXXA® (pegloticase) is the first and only biologic approved by the FDA to treat adults living with uncontrolled gout, a painful and debilitating inflammatory condition with which people continue to have abnormally high levels of uric acid and symptoms despite the use of conventional therapies. In 2022, the FDA approved expanding labeling to include co-administration with the immunomodulator methotrexate, based on results from the MIRROR randomized controlled trial, which showed significant improvements in efficacy and safety, including a reduction in infusion reactions. Gout is a chronic, progressive inflammatory form of arthritis that is caused by high urate levels in the body. Tiny needle-like crystals can form and build up almost anywhere in the body. Patients with uncontrolled gout continue to have high levels of uric acid and ongoing symptoms of gout despite the use of oral urate-lowering therapies. Uncontrolled gout is a chronic, systemic disease, and if not addressed can have significant clinical consequences. KRYSTEXXA (pegloticase) is indicated for the treatment of chronic gout in adult patients who have failed to normalize serum uric acid and whose signs and symptoms are inadequately controlled with xanthine oxidase inhibitors at the maximum medically appropriate dose or for whom these drugs are contraindicated. IMPORTANT SAFETY INFORMATION
Anaphylaxis and infusion reactions have been reported to occur during and after administration of KRYSTEXXA. Anaphylaxis may occur with any infusion, including a first infusion and generally manifests within 2 hours of the infusion. Delayed hypersensitivity reactions have also been reported. KRYSTEXXA should be administered in healthcare settings and by healthcare providers prepared to manage anaphylaxis and infusion reactions. Patients should be premedicated with antihistamines and corticosteroids and closely monitored for anaphylaxis for an appropriate period after administration of KRYSTEXXA. Serum uric acid levels should be monitored prior to each infusion and treatment discontinued if levels increase to above 6 mg/dL, particularly when 2 consecutive levels above 6 mg/dL are observed.
In patients with G6PD deficiency. Gout Flares: An increase in gout flares is frequently observed upon initiation of anti-hyperuricemic therapy, including KRYSTEXXA. Gout flare prophylaxis with a non-steroidal anti-inflammatory drug (NSAID) or colchicine is recommended starting at least 1 week before initiation of KRYSTEXXA therapy and lasting at least 6 months, unless medically contraindicated or not tolerated. The most commonly reported adverse reactions (≥5%) are:
KRYSTEXXA co-administration with methotrexate trial: gout flares, arthralgia, COVID-19, nausea and fatigue; KRYSTEXXA alone: gout flares, arthralgia, COVID-19, nausea, fatigue, infusion reactions, pain in extremity, hypertension and vomiting. Please see Full Prescribing Information, including Boxed Warning.
Otezla® (apremilast) is an oral small-molecule inhibitor of phosphodiesterase 4 (PDE4) specific for cyclic adenosine monophosphate (cAMP). PDE4 inhibition results in increased intracellular cAMP levels, which is thought to indirectly modulate the production of inflammatory mediators. The specific mechanism(s) by which Otezla exerts its therapeutic action in patients is not well defined. Since its initial FDA approval in 2014, Otezla has been prescribed to more than 840,000 patients worldwide. Otezla U.S. IMPORTANT SAFETY INFORMATION
Diarrhea, Nausea, and Vomiting: Cases of severe diarrhea, nausea, and vomiting were associated with the use of Otezla. Most events occurred within the first few weeks of treatment. In some cases, patients were hospitalized. Patients 65 years of age or older and patients taking medications that can lead to volume depletion or hypotension may be at a higher risk of complications from severe diarrhea, nausea, or vomiting. Monitor patients who are more susceptible to complications of diarrhea or vomiting; advise patients to contact their healthcare provider. Consider Otezla dose reduction or suspension if patients develop severe diarrhea, nausea, or vomiting Depression: Carefully weigh the risks and benefits of treatment with Otezla for patients with a history of depression and/or suicidal thoughts/behavior, or in patients who develop such symptoms while on Otezla. Patients, caregivers, and families should be advised of the need to be alert for the emergence or worsening of depression, suicidal thoughts or other mood changes, and they should contact their healthcare provider if such changes occur Plaque Psoriasis: Treatment with Otezla is associated with an increase in depression. During clinical trials in patients with moderate to severe plaque psoriasis, 1.3% (12/920) of patients reported depression compared to 0.4% (2/506) on placebo. Depression was reported as serious in 0.1% (1/1308) of patients exposed to Otezla, compared to none in placebo-treated patients (0/506). Suicidal behavior was observed in 0.1% (1/1308) of patients on Otezla, compared to 0.2% (1/506) on placebo. One patient treated with Otezla attempted suicide; one patient on placebo committed suicide Psoriatic Arthritis: Treatment with Otezla is associated with an increase in depression. During clinical trials, 1.0% (10/998) reported depression or depressed mood compared to 0.8% (4/495) treated with placebo. Suicidal ideation and behavior was observed in 0.2% (3/1441) of patients on Otezla, compared to none in placebo-treated patients. Depression was reported as serious in 0.2% (3/1441) of patients exposed to Otezla, compared to none in placebo-treated patients (0/495). Two patients who received placebo committed suicide compared to none on Otezla Behçet's Disease: Treatment with Otezla is associated with an increase in depression. During the clinical trial, 1% (1/104) reported depression or depressed mood compared to 1% (1/103) treated with placebo. No instances of suicidal ideation or behavior were reported in patients treated with Otezla or treated with placebo Weight Decrease: Monitor body weight regularly; evaluate unexplained or clinically significant weight loss, and consider discontinuation of Otezla Plaque Psoriasis: Body weight loss of 5-10% occurred in 12% (96/784) of patients with moderate to severe plaque psoriasis treated with Otezla and in 5% (19/382) of patients treated with placebo. Body weight loss of ≥10% occurred in 2% (16/784) of patients treated with Otezla compared to 1% (3/382) of patients treated with placebo Psoriatic Arthritis: Body weight loss of 5-10% was reported in 10% (49/497) of patients taking Otezla and in 3.3% (16/495) of patients taking placebo Behçet's Disease: Body weight loss of >5% was reported in 4.9% (5/103) of patients taking Otezla and in 3.9% (4/102) of patients taking placebo Use in Specific Populations
Otezla has not been studied in pregnant women. Advise pregnant women of the potential risk of fetal loss. Please click here for Otezla® Full Prescribing Information. TAVNEOS U.S. PRESCRIBING INFORMATION TAVNEOS U.S. IMPORTANT SAFETY INFORMATION Serious hypersensitivity to avacopan or to any of the excipients. Hepatotoxicity: Serious cases of hepatic injury have been observed in patients taking TAVNEOS, including life-threatening events. Obtain liver test panel before initiating TAVNEOS, every 4 weeks after start of therapy for six months and as clinically indicated thereafter. Monitor patients closely for hepatic adverse reactions, and consider pausing or discontinuing treatment as clinically indicated (refer to section 5.1 of the Prescribing Information). TAVNEOS is not recommended for patients with active, untreated and/or uncontrolled chronic liver disease (e.g., chronic active hepatitis B, untreated hepatitis C, uncontrolled autoimmune hepatitis) and cirrhosis. Consider the risk and benefit before administering this drug to a patient with liver disease. Serious Hypersensitivity Reactions: Cases of angioedema occurred in a clinical trial, including one serious event requiring hospitalization. Discontinue immediately if angioedema occurs and manage accordingly. TAVNEOS must not be re-administered unless another cause has been established. Hepatitis B Virus (HBV) Reactivation: Hepatitis B reactivation, including life threatening hepatitis B, was observed in the clinical program. Screen patients for HBV. For patients with evidence of prior infection, consult with physicians with expertise in HBV and monitor during TAVNEOS therapy and for six months following. If patients develop HBV reactivation, immediately discontinue TAVNEOS and concomitant therapies associated with HBV reactivation, and consult with experts before resuming. The most common adverse reactions (≥5% of patients and higher in the TAVNEOS group vs. prednisone group) were: nausea, headache, hypertension, diarrhea, vomiting, rash, fatigue, upper abdominal pain, dizziness, blood creatinine increased, and paresthesia. Avoid coadministration of TAVNEOS with strong and moderate CYP3A4 enzyme inducers. Reduce TAVNEOS dose when co-administered with strong CYP3A4 enzyme inhibitorsCYP3A4 enzyme inhibitors to 30 mg once daily. Monitor for adverse reactions and consider dose reduction of certain sensitive CYP3A4 substrates. Please see Full Prescribing Information and Medication Guide.
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. 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 2023, Amgen was named one of "America's Greatest Workplaces" by Newsweek, one of "America's Climate Leaders" by USA Today and one of the "World's Best Companies" by TIME. For more information, visit Amgen.com and follow us on X (formerly known as Twitter), LinkedIn, Instagram, TikTok, YouTube 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 BeiGene, Ltd. or Kyowa-Kirin Co., Ltd.), the performance of OtezlaOtezla® (apremilast) (including anticipated OtezlaOtezla sales growth and the timing of non-GAAP EPS accretion), the Teneobio, Inc. acquisition, the ChemoCentryx, Inc. acquisition, or the Horizon Therapeutics plc acquisition (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.
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