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    AMGN   US0311621009

AMGEN INC.

(AMGN)
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Amgen Announces U.S. Food and Drug Administration Approves Repatha in Pediatric Patients Age 10 and Older with Heterozygous Familial Hypercholesterolemia

09/24/2021 | 08:09pm EDT

Amgen announced that the U.S. Food and Drug Administration (FDA) has approved Repatha® (evolocumab) as an adjunct to diet and other low-density lipoprotein cholesterol (LDL-C)-lowering therapies for the treatment of pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH) to reduce LDL-C. HeFH is an inherited, genetic condition with a prevalence of one in 250 people worldwide. High levels of LDL-C starting at birth accelerate the development of atherosclerotic cardiovascular disease, leading to an overall increased risk of cardiovascular events, including heart attack and other vascular conditions, at an earlier age. Children with familial hypercholesterolemia (FH) can be normal weight, have a good diet, exercise enough and still have high LDL-C. The approval is based on the HAUSER-RCT Phase 3b study evaluating the safety and efficacy of Repatha in pediatric patients, 10 - 17 years of age, with HeFH. Monthly treatment with Repatha reduced LDL-C by mean 38% (95% CI: 45%, 31%; p 5% of patients treated with Repatha and occurring more frequently than placebo) included nasopharyngitis, headache, oropharyngeal pain, influenza and upper respiratory tract infection. The FDA also approved Repatha as an adjunct to other LDL-C lowering therapies for the treatment of homozygous familial hypercholesterolemia (HoFH) for younger pediatric patients. Repatha was already approved for treatment in HoFH patients aged 13 and older and is now available as a treatment for patients aged 10 and older.


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Financials (USD)
Sales 2021 26 010 M - -
Net income 2021 5 799 M - -
Net Debt 2021 22 276 M - -
P/E ratio 2021 20,1x
Yield 2021 3,42%
Capitalization 115 B 115 B -
EV / Sales 2021 5,29x
EV / Sales 2022 4,96x
Nbr of Employees 24 300
Free-Float 99,8%
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Number of Analysts 26
Last Close Price 203,13 $
Average target price 243,14 $
Spread / Average Target 19,7%
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Managers and Directors
Robert A. Bradway Chairman, President & Chief Executive Officer
Peter H. Griffith Chief Financial Officer & Executive Vice President
David M. Reese Executive Vice President-Research & Development
Darryl Sleep Chief Medical Officer & Senior VP-Global Medical
Mike Zahigian Chief Information Officer & Senior Vice President
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