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"We 观看比赛直播 are excited about today's approval 世界杯直播频道 of Repatha in the U.S. as patients and 2026世界杯直播赛程 physicians will now have a new treatment option to 世界杯直播频道 lower LDL cholesterol," said Sean E. Harper, M.D., executive vice president of
2026世界杯直播赛程 2026世界杯直播赛程 Research and Development at Amgen. "Data from key clinical studies have shown that Repatha significantly reduces 世界杯直播频道 LDL cholesterol in patients who have not been able FIFA 2026开球时间 to lower their 世界杯比赛时间 LDL cholesterol through
2026世界杯直播赛程 世界杯直播频道 diet and statins alone. At
世界杯比赛时间 2026世界杯直播赛程 2026世界杯直播赛程
Elevated LDL-C is an abnormality 世界杯比赛时间 of cholesterol and/or 2026世界杯直播赛程 fats in the blood. 世界杯比赛时间 世界杯比赛时间 FIFA 2026开球时间 世界杯比赛时间 2,3 In the U.S., 世界杯比赛时间 there are approximately 11 million people with ASCVD and/or familial hypercholesterolemia (FH), who have uncontrolled 观看比赛直播 levels of LDL-C over 70 mg/dL, despite 世界杯直播频道 treatment with statins or 世界杯直播频道 other 世界杯直播频道 cholesterol-lowering FIFA 2026开球时间 2026世界杯直播赛程 观看比赛直播 therapies. 4,5 Familial hypercholesterolemia is caused by genetic 世界杯直播频道 mutations that lead FIFA 2026开球时间 to high levels of LDL-C at an early age. 观看比赛直播 世界杯直播频道 6 It is estimated 观看比赛直播 that one million people in the U.S. have FH (heterozygous and homozygous forms), yet less 世界杯直播频道 than one percent FIFA 2026开球时间 are diagnosed. 观看比赛直播 2026世界杯直播赛程 7
"Through PCSK9 inhibition, evolocumab substantially reduces LDL FIFA 2026开球时间 or 'bad' cholesterol, a 世界杯比赛时间 well-validated, modifiable risk factor for cardiovascular disease," said
世界杯比赛时间 2026世界杯直播赛程 FIFA 2026开球时间 世界杯比赛时间 世界杯比赛时间 FIFA 2026开球时间
In Phase 3 trials, adding Repatha to background lipid-lowering therapy that included statins resulted 世界杯比赛时间 in intensive reductions in LDL-C levels 观看比赛直播 with favorable effects on 2026世界杯直播赛程 FIFA 2026开球时间 other lipid parameters. In patients with FIFA 2026开球时间 世界杯比赛时间 FIFA 2026开球时间 clinical ASCVD or HeFH, Repatha reduced LDL-C by approximately 54 to 77 percent compared FIFA 2026开球时间 with placebo. 8 In a pivotal Phase 3 trial, 90 percent of clinical ASCVD patients who received Repatha in addition to maximum FIFA 2026开球时间 世界杯比赛时间 doses of statins achieved a LDL-C level less than 70 mg/dL. 世界杯比赛时间 世界杯直播频道 5 In patients with HoFH, Repatha reduced LDL-C by approximately 30 percent 观看比赛直播 compared with placebo. FIFA 2026开球时间 8
Repatha is generally well-tolerated with an established safety profile. The most common 世界杯比赛时间 adverse reactions FIFA 2026开球时间 that occurred in greater than 5 percent of the Repatha group, and 世界杯直播频道 more frequently FIFA 2026开球时间 than in the placebo group, were nasopharyngitis, upper respiratory tract infection, influenza, back pain and 世界杯直播频道 injection site reactions. FIFA 2026开球时间 观看比赛直播 世界杯直播频道 世界杯直播频道 世界杯比赛时间 世界杯比赛时间 8
Repatha is available as a single-use 140 mg prefilled SureClick
FIFA 2026开球时间 ® autoinjector or prefilled syringe that patients can self-administer at the 世界杯比赛时间 recommended dose for adults of 140 mg every two weeks or 420 mg once FIFA 2026开球时间 a month. For adults with HoFH, the recommended dose 世界杯直播频道 is 420
世界杯直播频道 世界杯直播频道 FIFA 2026开球时间 世界杯直播频道 世界杯直播频道 mg once a month.
FIFA 2026开球时间
The U.S. Wholesale Acquisition FIFA 2026开球时间 Cost (WAC) price of Repatha 世界杯直播频道 is
2026世界杯直播赛程 世界杯比赛时间
"
2026世界杯直播赛程 世界杯直播频道
Repatha is expected to be available in the U.S. FIFA 2026开球时间 next 世界杯比赛时间 week.
Today's U.S. approval 观看比赛直播 of Repatha follows the marketing authorization of 世界杯直播频道 Repatha in
FIFA 2026开球时间 世界杯直播频道 世界杯直播频道 世界杯比赛时间 观看比赛直播 世界杯比赛时间
Please contact Amgen Medinfo at 800-77-
观看比赛直播 世界杯直播频道 世界杯比赛时间
About Repatha™ (evolocumab)
Repatha™ (evolocumab) is a human monoclonal antibody that inhibits proprotein convertase subtilisin/kexin type 9 (PCSK9).
世界杯比赛时间 世界杯比赛时间 世界杯比赛时间 1 Repatha binds to PCSK9 and inhibits circulating PCSK9 from binding to 2026世界杯直播赛程 the low-density lipoprotein (LDL) FIFA 2026开球时间 receptor (LDLR), 世界杯直播频道 preventing PCSK9-mediated LDLR degradation and permitting LDLR to recycle back to
世界杯直播频道 世界杯直播频道 观看比赛直播 2026世界杯直播赛程 the liver cell surface. By inhibiting the binding of PCSK9 to LDLR, Repatha increases the number of LDLRs available to clear LDL from the blood, thereby lowering LDL-C levels.
世界杯直播频道 8
GLAGOV, the intravascular ultrasound study, is underway to determine 世界杯比赛时间 the 世界杯直播频道 effect of Repatha 世界杯比赛时间 on coronary atherosclerosis 2026世界杯直播赛程 in approximately 950 patients undergoing cardiac catheterization to test the hypothesis 世界杯直播频道 观看比赛直播 FIFA 2026开球时间 世界杯直播频道 of robust LDL-C reduction leading to a reduction or a change in the build-up of plaque in the arteries. Results from the GLAGOV study are expected in 2016.
The FOURIER outcomes trial is designed to evaluate whether treatment 世界杯直播频道 with Repatha in combination with statin therapy compared to 世界杯直播频道 placebo plus statin therapy reduces the risk of recurrent cardiovascular events
2026世界杯直播赛程 FIFA 2026开球时间 in patients with high cholesterol and clinically evident cardiovascular disease and completed patient enrollment in
2026世界杯直播赛程
Important U.S. Product Information
Repatha is indicated as an adjunct to diet and:
Limitations of Use
The effect of Repatha on cardiovascular morbidity and mortality has not been determined.
Important Safety Information
Repatha™ is contraindicated in patients with a history of a FIFA 2026开球时间 serious hypersensitivity reaction to Repatha. Hypersensitivity reactions (e.g. rash, urticaria) have been reported in patients treated with Repatha,
2026世界杯直播赛程 世界杯比赛时间 FIFA 2026开球时间 世界杯直播频道 世界杯直播频道 including some that led to discontinuation of therapy. If signs or symptoms of 观看比赛直播 serious allergic reactions occur, discontinue treatment with Repatha, treat according to the standard of care, and monitor until
世界杯比赛时间 世界杯比赛时间 FIFA 2026开球时间 观看比赛直播 世界杯比赛时间 FIFA 2026开球时间 signs and symptoms resolve.
The most common adverse FIFA 2026开球时间 reactions (>5% of Repatha-treated patients 观看比赛直播 and more common 观看比赛直播 than placebo) were: nasopharyngitis, upper FIFA 2026开球时间 respiratory tract infection, influenza, back pain, and injection site reactions. 世界杯直播频道 世界杯直播频道 FIFA 2026开球时间
In FIFA 2026开球时间 a 2026世界杯直播赛程 52-week trial, 世界杯直播频道 adverse reactions led to FIFA 2026开球时间 2026世界杯直播赛程 discontinuation of treatment in 2.2% of Repatha-treated patients and 1% of placebo-treated patients. The most 世界杯比赛时间 common adverse reaction that led to Repatha treatment 世界杯比赛时间 FIFA 2026开球时间 世界杯直播频道 世界杯比赛时间 discontinuation and occurred at 世界杯比赛时间 a rate greater than placebo was myalgia (0.3% versus 0% for Repatha and placebo, respectively).
Adverse reactions from a pool of the 52-week trial and seven 12-week trials, included:
Local injection site reactions that occurred in 3.2% and 3.0% of Repatha-treated and placebo-treated patients, respectively. The most common injection site reactions were erythema, pain, and bruising. The proportions 世界杯比赛时间 of 世界杯直播频道 世界杯比赛时间 patients who discontinued treatment due to local injection site 观看比赛直播 reactions in Repatha-treated patients and placebo-treated patients were 0.1% and 0%, respectively.
Allergic 观看比赛直播 reactions occurred in 5.1% and 4.6% of Repatha-treated and placebo-treated patients, respectively. The FIFA 2026开球时间 most common allergic reactions were rash (1.0% versus 0.5% for Repatha 世界杯直播频道 and placebo, respectively), 世界杯直播频道 世界杯比赛时间 FIFA 2026开球时间 eczema (0.4% versus 0.2%), erythema 观看比赛直播 (0.4% versus 0.2%), and urticaria (0.4% FIFA 2026开球时间 versus 0.1%).
Neurocognitive events were reported in less than or equal to 0.2% in Repatha-treated 世界杯直播频道 and placebo-treated patients.
In a pool of placebo- and active-controlled trials, as well as open-label extension studies that followed them, a FIFA 2026开球时间 total of 1609 世界杯比赛时间 patients 2026世界杯直播赛程 treated with Repatha had at least one LDL-C value < 25 mg/dL. Changes to background lipid-altering 世界杯直播频道 therapy were not made in response to low LDL-C values, and Repatha dosing was not modified or interrupted on this basis. Although adverse consequences of very low LDL-C were 世界杯比赛时间 FIFA 2026开球时间 not identified in these trials, the long-term effects of very low levels of LDL-C induced by Repatha are unknown.
Musculoskeletal adverse reactions were reported in 14.3% of Repatha-treated patients and 12.8% of 世界杯直播频道 placebo-treated patients. The most common adverse reactions that occurred FIFA 2026开球时间 at a rate greater than placebo were FIFA 2026开球时间 FIFA 观看比赛直播 2026开球时间 back pain (3.2% versus 2.9% for Repatha and placebo, respectively), arthralgia (2.3% versus 2.2%), and myalgia (2.0% versus 1.8%).
In 49 patients with 观看比赛直播 homozygous familial hypercholesterolemia studied in a 12-week, double-blind, randomized, FIFA 2026开球时间 placebo-controlled trial, 世界杯比赛时间 33 patients received 420 mg of FIFA 2026开球时间 Repatha subcutaneously once 世界杯直播频道 monthly. The 世界杯比赛时间 世界杯比赛时间 2026世界杯直播赛程 adverse reactions that occurred in at least 2 (6.1%) 2026世界杯直播赛程 Repatha-treated patients 世界杯比赛时间 and more frequently than in placebo-treated 观看比赛直播 patients, included upper respiratory tract infection (9.1% versus 6.3%), influenza 世界杯比赛时间 FIFA 2026开球时间 (9.1% versus 0%), gastroenteritis (6.1% versus 世界杯比赛时间 0%), and nasopharyngitis (6.1% versus 0%).
Repatha is a human monoclonal antibody. As with all therapeutic proteins, there 世界杯比赛时间 is a potential 世界杯比赛时间 for immunogenicity with Repatha.
About Amgen Cardiovascular
Building on more than three decades of experience in developing biotechnology medicines for patients with serious illnesses,
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Forward-Looking Statements
This news release contains forward-looking statements 世界杯直播频道 that are based on management's current expectations and beliefs FIFA 2026开球时间 世界杯直播频道 and are subject to a number of risks, uncertainties and assumptions that could cause
FIFA 2026开球时间 actual results 世界杯直播频道 to differ materially from those described. All statements, other than statements of historical fact, are statements that could be deemed forward-looking 世界杯直播频道 statements, including estimates 世界杯比赛时间 世界杯直播频道 of
FIFA 2026开球时间 FIFA 2026开球时间 观看比赛直播 世界杯直播频道 revenues, operating margins, capital expenditures, cash, other financial metrics, expected legal, arbitration, political, regulatory or clinical results or practices, customer and prescriber 世界杯比赛时间 patterns or
世界杯直播频道 FIFA 2026开球时间 世界杯直播频道 FIFA 2026开球时间 practices, reimbursement 世界杯比赛时间 FIFA 2026开球时间 activities and outcomes and other such estimates and results. 世界杯直播频道 Forward-looking statements involve significant risks FIFA 2026开球时间 and uncertainties, including those 世界杯比赛时间 discussed below and more fully
世界杯比赛时间 FIFA 2026开球时间 described in the
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No 世界杯直播频道 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 FIFA 2026开球时间 FIFA 2026开球时间 世界杯直播频道 FIFA 2026开球时间 products cannot be guaranteed and movement from concept to product 观看比赛直播 is uncertain; consequently, there can be no guarantee that any particular product candidate or development of a new indication for an existing 世界杯直播频道 世界杯直播频道 世界杯比赛时间 product will be successful and become a commercial product. Further, preclinical results do not guarantee safe and effective performance of product 世界杯比赛时间 candidates in humans. The complexity of the human body cannot be FIFA 2026开球时间 perfectly, or 世界杯直播频道 sometimes, even adequately modeled by computer or cell culture systems or animal models. 观看比赛直播 The length of time that it takes for us to complete clinical trials and 观看比赛直播 obtain regulatory 观看比赛直播 世界杯比赛时间 approval FIFA 2026开球时间 for product marketing has in the past varied and we expect similar variability in the future. We develop product 观看比赛直播 candidates internally and through licensing collaborations, partnerships and joint FIFA 2026开球时间 2026世界杯直播赛程 世界杯比赛时间 世界杯比赛时间 世界杯直播频道 ventures. 观看比赛直播 Product 世界杯直播频道 candidates that are 观看比赛直播 derived from relationships may be 观看比赛直播 世界杯直播频道 subject to disputes between the parties or may prove to be not as effective or as safe 世界杯直播频道 as we may have believed at the FIFA 2026开球时间 time of entering 世界杯比赛时间 FIFA 2026开球时间 FIFA 2026开球时间 into 世界杯直播频道 such relationship. Also, we or others could identify 世界杯直播频道 safety, 世界杯直播频道 side effects or manufacturing problems with our products after they are on the market. Our business may be 世界杯直播频道 FIFA 2026开球时间 impacted by government investigations, FIFA 2026开球时间 观看比赛直播 世界杯比赛时间 世界杯直播频道 世界杯比赛时间 2026世界杯直播赛程 litigation and products liability claims. We depend on third parties for a significant portion 世界杯比赛时间 of our manufacturing capacity for the supply of certain of our current and future products and limits on supply 观看比赛直播 may constrain sales of certain of our current products and product candidate development.
In addition, sales of our products are affected 2026世界杯直播赛程 by the reimbursement FIFA 2026开球时间 policies imposed by third-party payors, including governments, private insurance plans and managed 世界杯直播频道 FIFA 2026开球时间 care providers and may be affected by 观看比赛直播 regulatory, 2026世界杯直播赛程 FIFA 2026开球时间 世界杯比赛时间 世界杯直播频道 clinical 世界杯比赛时间 and guideline developments and domestic and international trends toward managed 2026世界杯直播赛程 care FIFA 2026开球时间 and healthcare cost FIFA 2026开球时间 containment as well as U.S. legislation affecting pharmaceutical pricing and reimbursement. FIFA 2026开球时间 2026世界杯直播赛程 世界杯直播频道 FIFA 2026开球时间 世界杯直播频道 Government and others' 世界杯比赛时间 regulations and reimbursement policies may affect the development, usage and pricing of our products. In addition, we compete with other companies FIFA 2026开球时间 with respect to some of our marketed 观看比赛直播 观看比赛直播 观看比赛直播 世界杯比赛时间 products as well 世界杯比赛时间 as for the discovery and development of new 世界杯比赛时间 products. We believe that some of our newer products, product candidates or new indications for existing products, may face competition when and 世界杯直播频道 世界杯直播频道 观看比赛直播 FIFA 观看比赛直播 2026开球时间 世界杯直播频道 观看比赛直播 as they are approved and marketed. Our products may compete against products that 观看比赛直播 have lower prices, established reimbursement, superior performance, are easier to administer, or that are otherwise competitive 观看比赛直播 with our products. 世界杯直播频道 In addition, 世界杯比赛时间 while we routinely obtain patents for our products and technology, the protection offered by our patents 观看比赛直播 FIFA 2026开球时间 and patent applications may be 世界杯直播频道 challenged, invalidated or 世界杯比赛时间 circumvented 世界杯直播频道 世界杯直播频道 世界杯比赛时间 世界杯比赛时间 by our competitors FIFA 2026开球时间 and there can be 世界杯直播频道 no guarantee of our 世界杯直播频道 ability to obtain or maintain patent protection for our products or product candidates. We 世界杯直播频道 cannot guarantee that we 世界杯比赛时间 will be able to produce commercially FIFA 2026开球时间 世界杯直播频道 世界杯直播频道 FIFA 2026开球时间 2026世界杯直播赛程 successful 2026世界杯直播赛程 products or maintain the commercial success of our 世界杯比赛时间 existing products. Our stock price may be 观看比赛直播 世界杯直播频道 affected by actual or perceived market 2026世界杯直播赛程 世界杯比赛时间 opportunity, competitive position, 世界杯比赛时间 and success or failure of 2026世界杯直播赛程 观看比赛直播 2026世界杯直播赛程 世界杯比赛时间 观看比赛直播 FIFA 2026开球时间 our products or product candidates. Further, the discovery 世界杯直播频道 of FIFA 2026开球时间 significant problems with a product similar to one of our 世界杯直播频道 products that implicate an 世界杯直播频道 entire class of products could have a material 世界杯比赛时间 adverse effect FIFA 2026开球时间 2026世界杯直播赛程 on sales of the affected products and on our business and results of operations. Our efforts to integrate the operations of FIFA 2026开球时间 2026世界杯直播赛程 观看比赛直播 companies we have acquired may not be successful. We may experience difficulties, 世界杯直播频道 FIFA 2026开球时间 delays or unexpected costs and not 世界杯比赛时间 achieve anticipated benefits and savings from our ongoing restructuring plan. Our business performance could affect or limit the ability of our Board of Directors to declare 观看比赛直播 世界杯直播频道 世界杯比赛时间 a dividend or their ability to pay a 世界杯直播频道 dividend or repurchase our common stock.
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