Key shows embrace the primary findings displaying dazodalibep improved main biomarkers in Sjögren’s illness, in addition to information on therapy outcomes for uncontrolled gout primarily based on a post-hoc evaluation of the MIRROR trial for KRYSTEXXA ® (pegloticase) with methotrexate.
“We’re deeply dedicated to advancing affected person care by means of steady innovation and rigorous science. The info introduced at EULAR 2024 additional display our efforts to deal with complicated illnesses,” mentioned Jay Bradner , M.D., government vice chairman, Analysis and Improvement, and chief scientific officer at Amgen. “By advancing scientific analysis, we aren’t solely enhancing our understanding of those circumstances, but additionally paving the way in which for simpler remedies which have the potential to considerably enhance affected person outcomes.”
Extra shows embrace new long-term information from the FOREMOST research of Otezla ® (apremilast) in early oligoarticular psoriatic arthritis, in addition to a post-hoc evaluation of TAVNEOS ® (avacopan) versus prednisone taper in sufferers with extreme lively MPA/GPA and lively ear, nostril or throat manifestations.
For extra info on the Amgen abstracts, see beneath.
Abstracts and Presentation Instances:
Amgen-Sponsored Abstracts
Dazodalibep
- CD40L blockade with dazodalibep considerably improves illness exercise, swollen and tender joint counts, whereas lowering a number of T- and B-cell biomarkers within the MIDORA part 2 research of sufferers with moderate-to-severe lively rheumatoid arthritis
Summary #AB0746, Rheumatoid Arthritis (Publication solely) - Dazodalibep (anti-CD40L) successfully reduces a number of proteins related to B-, T, and dendritic cell biomarkers in Sjögren’s illness: Corroboration of immunophenotyping findings from the ALISS part 2 research
Summary #OP0058, Scientific Summary Periods: New Targets and New Therapies in Sjön’s Illness (Oral Summary Shows), Wednesday, June 12 from 5:00 to five:10 p.m. CDT
Sjögren’s Illness
- World burden of Sj ö gren’s illness (SjD): Findings from a scientific literature evaluate (SLR) of humanistic and medical outcomes
Summary #AB0815, Sjögren`s syndrome (Publication Solely)
KRYSTEXXA ® (pegloticase)
- Achievement of “gout remission” throughout intensive urate-lowering over 52 weeks of pegloticase remedy
Summary #POS0239, Scientific Poster Excursions: Gout therapy in 2024 (Poster Excursions), Friday, June 14 at 9:30 a.m. CDT - Affect of acute gout flare and serum urate reducing on biomarkers of systemic irritation
Summary #AB0114, Crystal associated problems (Publication Solely) - Affected person-reported high quality of life in uncontrolled gout and modifications with intensive urate-lowering: Comparability of tophaceous and non-tophaceous sufferers
Summary #AB0112, Crystal associated dysfunction s (Publication Solely) - Pre-infusion glucocorticoid discount/elimination in sufferers with uncontrolled gout handled with pegloticase and methotrexate: Expertise of 1 group rheumatology apply
Summary #POS0936, Crystal associated problems (Poster View), Friday, June 14 at 9:30 a.m. CDT
Uncontrolled Gout
- Heart problems, persistent kidney illness, ache, and psychological points in sufferers with managed vs. uncontrolled gout: A retrospective claims-based cohort evaluation
Summary #POS0569, Crystal associated problems (Poster View), Wednesday, June 12 at 3:30 p.m. CDT - The idea of gout remission as considered by rheumatologists, nephrologists, and first care physicians
Summary #POS0269, Scientific Poster Excursions: Gout therapy in 2024 (Poster Excursions), Friday, June 14 at 9:30 a.m. CDT - Therapy patterns and high quality of life in sufferers with managed and uncontrolled gout
Summary #POS0940, Crystal associated problems (Poster View), Friday, June 14 at 9:30 a.m. CDT
Otezla ® (apremilast)
- Apremilast reduces axial irritation in sufferers with psoriatic arthritis as assessed by CANDEN MRI scoring: Outcomes from the part 4 MOSAIC research
Summary #POS0982, Psoriatic arthritis (Poster View), Friday, June 14 at 9:30 a.m. CDT - Apremilast reduces irritation as measured by MRI, medical outcomes, and patient-reported outcomes in sufferers with psoriatic arthritis: Outcomes from the part 4 MOSAIC research
Summary #POS0968, Psoriatic arthritis (Poster View), Friday, June 14 at 9:30 a.m. CDT - Apremilast therapy in early oligoarticular psoriatic arthritis (PsA) improves medical and patient-reported outcomes for as much as 48 weeks – Information from the FOREMOST research
Summary #POS0976, Psoriatic arthritis (Poster View), Friday, June 14 at 9:30 a.m. CDT - Apremilast for psoriatic arthritis in the Netherlands : Actual-world information from the REWARD research
Summary #AB0453, Psoriatic arthritis (Publication Solely) - The usage of illness exercise thresholds for the Psoriatic Arthritis Impression of Illness (PsAID-12) questionnaire to evaluate affected person perceptions of illness burden in sufferers with early oligoarticular psoriatic arthritis handled with apremilast within the FOREMOST research
Summary #AB0473, Psoriatic arthritis (Publication Solely)
Prolia ® (denosumab)
- Comparative effectiveness of denosumab versus bisphosphonates amongst treatment-experienced postmenopausal girls with osteoporosis within the U.S. Medicare program
Summary #POS0089, Scientific Poster Excursions: Therapy Choices in Metabolic bone illnesses and Osteoporosis (Poster Excursions), Thursday, June 13 at 9:54 a.m. CDT - Comparative effectiveness of denosumab versus zoledronic acid amongst postmenopausal girls with osteoporosis within the U.S. Medicare program
Summary #POS0583, Different illnesses (Poster View), Thursday, June 13 at 9:30 a.m. CDT - Danger of fragility fracture after long-term discontinuation of osteoporosis therapy in po st-menopausal osteoporosis girls in France : A population-based research performed on the nationwide declare database (SNDS)
Summary #OP0035, Scientific Summary Periods: Danger elements and therapy in osteoporosis (Oral Summary Shows), Wednesday, June 12 at 4:50 p.m. CDT
TAVNEOS ® (avacopan)
- Avacopan versus prednisone taper in sufferers with ANCA-associated vasculitis and ear, nostril, or throat involvement
Summary #OP0174, Scientific Summary Periods: Vasculitis throughout completely different vessel sizes (Oral Summary Shows), Thursday, June 13 at 11:20 a.m. CDT - Information from the ADVOCATE trial on 28 sufferers with ANCA-associated vasculitis who obtained avacopan with out concomitant glucocorticoid use within the first 29 days
Summary #POS0246, Scientific Poster Excursions: Miscellaneous in Vasculitis (Poster Excursions), Friday, June 14 at 9:36 a.m. CDT
UPLIZNA ® ( inebilizumab-cdon )
- Burden of glucocorticoid use and related toxicities in commercially insured adults with IgG4-related illness
Summary #POS0357, Scientific Poster Excursions: IgG4 Associated Illness (Poster Excursions), Friday, June 14 at 2:45 p.m. CDT - Insights into the design and research inhabitants of MITIGATE: The primary multinational randomized managed medical trial in IgG4-related illness (IgG4-RD), evaluating the efficacy and security of inebilizumab
Summary #POS0347, Scientific Poster Excursions: IgG4 Associated Illness (Poster Excursions), Friday, June 14 at 2:45 p.m. CDT
Companion-Led Abstracts
Sjögren’s Illness
- The usage of pure language processing to characterize illness burden: Sexual misery in Sjögren’s illness
Summary #AB0793, Sjön`s syndrome (Publication Solely) - Utilizing social media listening to characterize the flare lexicon in sufferers with Sjögren’s illness
Summary #AB0794, Sjön`s syndrome (Publication Solely)
TAVNEOS ® (avacopan)
- Security and effectiveness of avacopan past 52 weeks: Expertise so far within the Early Entry Program (EAP)
Summary #POS0865, Vasculitis, small and medium dimension vessels (Poster View), Thursday, June 13 at 2:45 p.m. CDT - Design of AVACOSTAR: An actual-world research of avacopan in ANCA-associated vasculitis (AAV)
Summary #AB1241, Vasculitis, small and medium dimension vessels (Publication Solely)
Uncontrolled Gout
- Osteoporosis in sufferers with gout in the USA
Summary #POS0563, Crystal associated problems (Poster View), Wednesday, June 12 at 3:30 p.m. CDT
About KRYSTEXXA ® (pegloticase)
KRYSTEXXA ® (pegloticase) is the primary and solely biologic permitted by the FDA to deal with adults residing with uncontrolled gout, a painful and debilitating inflammatory situation with which individuals proceed to have abnormally excessive ranges of uric acid and signs regardless of the usage of typical therapies.
In 2022, the FDA permitted increasing labeling to incorporate co-administration with the immunomodulator methotrexate, primarily based on outcomes from the MIRROR randomized managed trial, which confirmed vital enhancements in efficacy and security, together with a discount in infusion reactions.
About Uncontrolled Gout
Gout is a persistent, progressive inflammatory type of arthritis that’s brought on by excessive urate ranges within the physique. Tiny needle-like crystals can kind and construct up nearly wherever within the physique. Sufferers with uncontrolled gout proceed to have excessive ranges of uric acid and ongoing signs of gout regardless of the usage of oral urate-lowering therapies. Uncontrolled gout is a persistent, systemic illness, and if not addressed can have vital medical penalties.
KRYSTEXXA U.S. Indication
KRYSTEXXA (pegloticase) is indicated for the therapy of persistent gout in grownup sufferers who’ve didn’t normalize serum uric acid and whose indicators and signs are inadequately managed with xanthine oxidase inhibitors on the most medically applicable dose or for whom these medication are contraindicated.
Limitations of Use: KRYSTEXXA shouldn’t be really helpful for the therapy of asymptomatic hyperuricemia.
KRYSTEXXA U.S. Vital Security Data
WARNING: ANAPHYLAXIS AND INFUSION REACTIONS, G6PD DEFICIENCY ASSOCIATED HEMOLYSIS AND METHEMOGLOBINEMIA
- Anaphylaxis and infusion reactions have been reported to happen throughout and after administration of KRYSTEXXA.
- Anaphylaxis could happen with any infusion, together with a primary infusion and usually manifests inside 2 hours of the infusion. Delayed hypersensitivity reactions have additionally been reported.
- KRYSTEXXA ought to be administered in healthcare settings and by healthcare suppliers ready to handle anaphylaxis and infusion reactions.
- Sufferers ought to be premedicated with antihistamines and corticosteroids and intently monitored for anaphylaxis for an applicable interval after administration of KRYSTEXXA.
- Serum uric acid ranges ought to be monitored prior to every infusion and therapy discontinued if ranges improve to above 6 mg/dL, notably when 2 consecutive ranges above 6 mg/dL are noticed.
- Sufferers in danger for glucose-6-phosphate dehydrogenase (G6PD) deficiency ought to be screened previous to beginning KRYSTEXXA. Hemolysis and methemoglobinemia have been reported with KRYSTEXXA in sufferers with G6PD deficiency. KRYSTEXXA is contraindicated in sufferers with G6PD deficiency.
CONTRAINDICATIONS
- In sufferers with G6PD deficiency.
- In sufferers with historical past of great hypersensitivity reactions, together with anaphylaxis, to KRYSTEXXA or any of its elements.
WARNINGS AND PRECAUTIONS
Gout Flares: A rise in gout flares is ceaselessly noticed upon initiation of anti-hyperuricemic remedy, together with KRYSTEXXA. Gout flare prophylaxis with a non-steroidal anti-inflammatory drug (NSAID) or colchicine is really helpful beginning a minimum of 1 week earlier than initiation of KRYSTEXXA remedy and lasting a minimum of 6 months, except medically contraindicated or not tolerated.
Congestive Coronary heart Failure: KRYSTEXXA has not been formally studied in sufferers with congestive coronary heart failure, however some sufferers within the pre-marketing placebo-controlled medical trials skilled exacerbation. Warning ought to be exercised in sufferers who’ve congestive coronary heart failure and sufferers ought to be intently monitored following infusion.
ADVERSE REACTIONS
Probably the most generally reported hostile 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, ache in extremity, hypertension and vomiting.
- KRYSTEXXA pre-marketing placebo-controlled trials: gout flares, infusion reactions, nausea, contusion or ecchymosis, nasopharyngitis, constipation, chest ache, anaphylaxis and vomiting.
Please see Full Prescribing Data, together with Boxed Warning.
About Otezla ® (apremilast)
Otezla ® (apremilast) is an oral small-molecule inhibitor of phosphodiesterase 4 (PDE4) particular for cyclic adenosine monophosphate (cAMP). PDE4 inhibition ends in elevated intracellular cAMP ranges, which is believed to not directly modulate the manufacturing of inflammatory mediators. The precise mechanism(s) by which Otezla exerts its therapeutic motion in sufferers shouldn’t be effectively outlined.
Since its preliminary FDA approval in 2014, Otezla has been prescribed to greater than 840,000 sufferers worldwide.
About Psoriatic Arthritis
Psoriatic arthritis is a persistent, inflammatory type of arthritis, which may trigger swelling, stiffness and ache in and across the joints that worsens over time and might lower bodily perform. It’s estimated that almost 38 million individuals worldwide have psoriatic arthritis. Round a 3rd of individuals residing with psoriasis could go on to develop psoriatic arthritis. If left untreated, psoriatic arthritis could cause incapacity.
Otezla U.S. Indications
Otezla (apremilast) is indicated for the therapy of grownup sufferers with plaque psoriasis who’re candidates for phototherapy or systemic remedy.
Otezla is indicated for the therapy of grownup sufferers with lively psoriatic arthritis.
Otezla is indicated for the therapy of grownup sufferers with oral ulcers related to Behçet’s Illness.
Otezla U.S. Vital Security Data
Contraindications
- Otezla is contraindicated in sufferers with a identified hypersensitivity to apremilast or to any of the excipients within the formulation
Warnings and Precautions
- Hypersensitivity: Hypersensitivity reactions, together with angioedema and anaphylaxis, have been reported throughout postmarketing surveillance. If indicators or signs of great hypersensitivity reactions happen, discontinue Otezla and institute applicable remedy
- Diarrhea, Nausea, and Vomiting: Instances of extreme diarrhea, nausea, and vomiting have been related to the usage of Otezla. Most occasions occurred throughout the first few weeks of therapy. In some instances, sufferers have been hospitalized. Sufferers 65 years of age or older and sufferers taking medicines that may result in quantity depletion or hypotension could also be at a better threat of issues from extreme diarrhea, nausea, or vomiting. Monitor sufferers who’re extra inclined to issues of diarrhea or vomiting; advise sufferers to contact their healthcare supplier. Take into account Otezla dose discount or suspension if sufferers develop extreme diarrhea, nausea, or vomiting
- Melancholy: Rigorously weigh the dangers and advantages of therapy with Otezla for sufferers with a historical past of despair and/or suicidal ideas/conduct, or in sufferers who develop such signs whereas on Otezla. Sufferers, caregivers, and households ought to be suggested of the must be alert for the emergence or worsening of despair, suicidal ideas or different temper modifications, and they need to contact their healthcare supplier if such modifications happen
- Plaque Psoriasis : Therapy with Otezla is related to a rise in despair. Throughout medical trials in sufferers with average to extreme plaque psoriasis, 1.3% (12/920) of sufferers reported despair in comparison with 0.4% (2/506) on placebo. Melancholy was reported as critical in 0.1% (1/1308) of sufferers uncovered to Otezla, in comparison with none in placebo-treated sufferers (0/506). Suicidal conduct was noticed in 0.1% (1/1308) of sufferers on Otezla, in comparison with 0.2% (1/506) on placebo. One affected person handled with Otezla tried suicide; one affected person on placebo dedicated suicide
- Psoriatic Arthritis : Therapy with Otezla is related to a rise in despair. Throughout medical trials, 1.0% (10/998) reported despair or depressed temper in comparison with 0.8% (4/495) handled with placebo. Suicidal ideation and conduct was noticed in 0.2% (3/1441) of sufferers on Otezla, in comparison with none in placebo-treated sufferers. Melancholy was reported as critical in 0.2% (3/1441) of sufferers uncovered to Otezla, in comparison with none in placebo-treated sufferers (0/495). Two sufferers who obtained placebo dedicated suicide in comparison with none on Otezla
- Behçet’s Illness : Therapy with Otezla is related to a rise in despair. In the course of the medical trial, 1% (1/104) reported despair or depressed temper in comparison with 1% (1/103) handled with placebo. No situations of suicidal ideation or conduct have been reported in sufferers handled with Otezla or handled with placebo
- Weight Lower: Monitor physique weight commonly; consider unexplained or clinically vital weight reduction, and take into account discontinuation of Otezla
- Plaque Psoriasis : Physique weight lack of 5-10% occurred in 12% (96/784) of sufferers with average to extreme plaque psoriasis handled with Otezla and in 5% (19/382) of sufferers handled with placebo. Physique weight lack of ≥10% occurred in 2% (16/784) of sufferers handled with Otezla in comparison with 1% (3/382) of sufferers handled with placebo
- Psoriatic Arthritis : Physique weight lack of 5-10% was reported in 10% (49/497) of sufferers taking Otezla and in 3.3% (16/495) of sufferers taking placebo
- Behçet’s Illness : Physique weight lack of >5% was reported in 4.9% (5/103) of sufferers taking Otezla and in 3.9% (4/102) of sufferers taking placebo
- Drug Interactions: Apremilast publicity was decreased when Otezla was co-administered with rifampin, a powerful CYP450 enzyme inducer; lack of Otezla efficacy could happen. Concomitant use of Otezla with CYP450 enzyme inducers (e.g., rifampin, phenobarbital, carbamazepine, phenytoin) shouldn’t be really helpful
Antagonistic Reactions
- Plaque Psoriasis : The most typical hostile reactions (≥ 5%) are diarrhea, nausea, higher respiratory tract an infection, and headache, together with pressure headache. Total, the security profile of Otezla in sufferers with gentle to average plaque psoriasis was in keeping with the security profile beforehand established in grownup sufferers with average to extreme plaque psoriasis
- Psoriatic Arthritis : The most typical hostile reactions (≥ 5%) are diarrhea, nausea, and headache
- Behçet’s Illness : The most typical hostile reactions (≥ 10%) are diarrhea, nausea, headache, and higher respiratory tract an infection.
Use in Particular Populations
- Otezla has not been studied in pregnant girls. Advise pregnant girls of the potential threat of fetal loss.
Please click on right here for Otezla ® Full Prescribing Data.
About TAVNEOS ® (avacopan)
TAVNEOS ® (avacopan), permitted by the FDA as an adjunctive therapy of extreme lively ANCA-associated vasculitis (GPA/MPA), is a first-in-class, orally administered small molecule that employs a novel, extremely focused mode of motion. TAVNEOS blocks the complement 5a receptor (C5aR) from binding C5a, the pro-inflammatory complement system fragment. That is presumed to dam C5a-mediated neutrophil activation and migration. The exact mechanism of TAVNEOS in ANCA-associated vasculitis (GPA/MPA) has not been definitively established.
About ANCA-Related Vasculitis
ANCA-associated vasculitis is an umbrella time period for a gaggle of multi-system autoimmune illnesses with small vessel irritation. Infected vessels could rupture or develop into occluded giving rise to a broad array of medical signs and indicators associated to a systemic inflammatory response which can lead to profound impairment within the kidneys, lungs and different organs. Previous to the approval of TAVNEOS in extreme lively ANCA-associated vasculitis (GPA/MPA), the mixture of immunosuppressants most frequently used for the therapy of ANCA-associated vasculitis (GPA/MPA) embrace cyclophosphamide or rituximab, mixed with each day glucocorticoids (steroids) for extended intervals, which could be related to vital medical penalties.
TAVNEOS U.S. Indication
TAVNEOS is indicated as an adjunctive therapy of grownup sufferers with extreme lively anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis (granulomatosis with polyangiitis [GPA] and microscopic polyangiitis [MPA]) together with commonplace remedy together with glucocorticoids. TAVNEOS doesn’t get rid of glucocorticoid use.
TAVNEOS U.S. Vital Security Data
Contraindications
Severe hypersensitivity to avacopan or to any of the excipients.
Warning and Precautions
Hepatotoxicity: Severe instances of hepatic harm have been noticed in sufferers taking TAVNEOS, together with life-threatening occasions. Get hold of liver check panel earlier than initiating TAVNEOS, each 4 weeks after begin of remedy for six months and as clinically indicated thereafter. Monitor sufferers intently for hepatic hostile reactions, and take into account pausing or discontinuing therapy as clinically indicated (check with part 5.1 of the Prescribing Data). TAVNEOS shouldn’t be really helpful for sufferers with lively, untreated and/or uncontrolled persistent liver illness (e.g., persistent lively hepatitis B, untreated hepatitis C, uncontrolled autoimmune hepatitis) and cirrhosis. Take into account the chance and profit earlier than administering this drug to a affected person with liver illness.
Severe Hypersensitivity Reactions: Instances of angioedema occurred in a medical trial, together with one critical occasion requiring hospitalization. Discontinue instantly if angioedema happens and handle accordingly. TAVNEOS should not be re-administered except one other trigger has been established.
Hepatitis B Virus (HBV) Reactivation: Hepatitis B reactivation, together with life threatening hepatitis B, was noticed within the medical program. Display screen sufferers for HBV. For sufferers with proof of prior an infection, seek the advice of with physicians with experience in HBV and monitor throughout TAVNEOS remedy and for six months following. If sufferers develop HBV reactivation, instantly discontinue TAVNEOS and concomitant therapies related to HBV reactivation, and seek the advice of with specialists earlier than resuming.
Severe Infections: Severe infections, together with deadly infections, have been reported in sufferers receiving TAVNEOS. The most typical critical infections reported in TAVNEOS group have been pneumonia and urinary tract infections. Keep away from use of TAVNEOS in sufferers with lively, critical an infection, together with localized infections. Take into account the dangers and advantages earlier than initiating TAVNEOS in sufferers with persistent an infection, at elevated threat of an infection or who’ve been to locations the place sure infections are widespread.
Antagonistic Reactions
The most typical hostile reactions (≥5% of sufferers and better within the TAVNEOS group vs. prednisone group) have been: nausea, headache, hypertension, diarrhea, vomiting, rash, fatigue, higher belly ache, dizziness, blood creatinine elevated, and paresthesia.
Drug Interactions
Keep away from coadministration of TAVNEOS with sturdy and average CYP3A4 enzyme inducers. Scale back TAVNEOS dose when co-administered with sturdy CYP3A4 enzyme inhibitors to 30 mg as soon as each day. Monitor for hostile reactions and take into account dose discount of sure delicate CYP3A4 substrates.
Please see Full Prescribing Data and Remedy Information.
About Amgen
Amgen discovers, develops, manufactures and delivers modern medicines to assist thousands and thousands of sufferers of their battle towards a few of the world’s hardest illnesses. Greater than 40 years in the past, Amgen helped to ascertain the biotechnology business and stays on the cutting-edge of innovation, utilizing know-how and human genetic information to push past what’s identified as we speak. Amgen is advancing a broad and deep pipeline that builds on its present portfolio of medicines to deal with most cancers, coronary heart illness, osteoporosis, inflammatory illnesses and uncommon illnesses.
In 2024, Amgen was named one of many “World’s Most Revolutionary Corporations” by Quick Firm and one in every of “America’s Greatest Giant Employers” by Forbes, amongst different exterior recognitions . Amgen is without doubt one of the 30 corporations that comprise the Dow Jones Industrial Common ® , and it’s also a part of the Nasdaq-100 Index ® , which incorporates the biggest and most modern non-financial corporations listed on the Nasdaq Inventory Market primarily based on market capitalization.
For extra info, go to Amgen.com and comply with Amgen on X , LinkedIn , Instagram , TikTok , YouTube and Threads .
Amgen Ahead-Trying Statements
This information launch comprises forward-looking statements which are primarily based on the present expectations and beliefs of Amgen. All statements, apart from statements of historic truth, are statements that might be deemed forward-looking statements, together with any statements on the end result, advantages and synergies of collaborations, or potential collaborations, with some other firm (together with BeiGene, Ltd. or Kyowa Kirin Co., Ltd.), the efficiency of Otezla ® (apremilast) (together with anticipated Otezla gross sales development and the timing of non-GAAP EPS accretion), our acquisitions of Teneobio, Inc., ChemoCentryx, Inc., or Horizon Therapeutics plc (together with the potential efficiency and outlook of Horizon’s enterprise, efficiency and alternatives, any potential strategic advantages, synergies or alternatives anticipated on account of such acquisition, and any projected impacts from the Horizon acquisition on our acquisition-related bills going ahead), in addition to estimates of revenues, working margins, capital expenditures, money, different monetary metrics, anticipated authorized, arbitration, political, regulatory or medical outcomes or practices, buyer and prescriber patterns or practices, reimbursement actions and outcomes, results of pandemics or different widespread well being issues on our enterprise, outcomes, progress, and different such estimates and outcomes. Ahead-looking statements contain vital dangers and uncertainties, together with these mentioned beneath and extra absolutely described within the Securities and Alternate Fee experiences filed by Amgen, together with our most up-to-date annual report on Type 10-Ok and any subsequent periodic experiences on Type 10-Q and present experiences on Type 8-Ok. Except in any other case famous, Amgen is offering this info as of the date of this information launch and doesn’t undertake any obligation to replace any forward-looking statements contained on this doc on account of new info, future occasions or in any other case.
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