/C O R R E C T I O N -- Amgen/

Rhea-AI Summary

Amgen (NASDAQ: AMGN) corrected a typo and announced AmgenNow, a U.S. direct-to-patient program launching for Repatha (evolocumab) on Oct 6, 2025. Repatha will be offered through AmgenNow at a monthly price of $239, described as nearly 60% below the current U.S. list price and the lowest among G-7 countries.

The program is open to all patients including the uninsured, those with high-deductible plans, cash payers, and participants in Medicare and Medicaid; enrolled patients are not subject to insurer step therapy or prior authorization. The announcement cites VESALIUS-CV Phase 3 results showing Repatha reduced major adverse cardiovascular events and notes Repatha has helped more than 5 million patients.

Positive

• Repatha price set at $239 monthly (~60% discount from U.S. list)
• AmgenNow open to uninsured, high-deductible, and cash-paying patients
• Program available to Medicare and Medicaid patients
• Patients using AmgenNow not subject to step therapy or prior authorization
• VESALIUS-CV Phase 3: Repatha reduced major adverse cardiovascular events
• Repatha has treated > 5 million patients

Negative

• None.

In the news release, AMGEN MAKES REPATHA® AVAILABLE THROUGH AMGENNOW, A DIRECT-TO-PATIENT PROGRAM IN THE U.S., issued 06-Oct-2025 by Amgen over PR Newswire, we are advised by the company that there was a typo in the first paragraph, first sentence and it has been corrected to read "evolocumab" rather than "evolucumab" as originally issued inadvertently. The complete, corrected release follows:

AMGEN MAKES REPATHA® AVAILABLE THROUGH AMGENNOW, A DIRECT-TO-PATIENT PROGRAM IN THE U.S.

Eligible Patients Can Access Repatha at Nearly 60% Discount From the List Price

THOUSAND OAKS, Calif., Oct. 6, 2025 /PRNewswire/ -- Amgen (NASDAQ: AMGN) today announced the launch of AmgenNow, a new direct-to-patient program starting with Repatha^® (evolocumab). This follows landmark results demonstrating Repatha significantly reduced the risk of major adverse cardiovascular events (MACE) in individuals without a prior history of heart attack or stroke in the VESALIUS-CV Phase 3 trial.

In support of the Trump Administration's efforts to lower drug prices for Americans, Repatha will be available through AmgenNow at a monthly price of $239, nearly 60% lower than the current U.S. list price. The program is open to all patients, including those who are uninsured or in high-deductible health plans or prefer to pay with cash or out of pocket. The new direct-to-patient price is the lowest among the economically developed (G-7) countries and is being offered exclusively for the first time to U.S. patients.  

"Amgen is committed to finding new ways to help patients benefit from our medicines," said Murdo Gordon, executive vice president of Global Commercial Operations at Amgen. "Repatha has already helped more than 5 million patients¹, and the AmgenNow program will make it easier for uninsured patients or those who choose to pay out-of-pocket to access treatment. This will allow even more Americans at increased risk of major adverse cardiovascular events to benefit from this effective medicine." 

Beginning today, AmgenNow will be available to all Repatha patients, including those who participate in government programs such as Medicare and Medicaid. Patients who use this program are not subject to insurer requirements for step therapy or prior authorization. The company also plans to make AmgenNow accessible via the TrumpRx website.

For more information, visit www.amgensupportplus.com/patient/repatha. 

About Repatha^® (evolocumab)
Repatha is a human monoclonal antibody that inhibits proprotein convertase subtilisin/kexin type 9 (PCSK9). Repatha binds to PCSK9 and inhibits circulating PCSK9 from binding to the low-density lipoprotein (LDL) receptor (LDLR), preventing PCSK9-mediated LDLR degradation and permitting LDLR to recycle back to 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. The clinical benefits and safety of Repatha have been studied for 15 years in 50 clinical trials with over 57,000 patients.^2,3

Repatha is approved in more than 74 countries, including the U.S., Japan, Canada and in all 28 countries that are members of the European Union. Applications in other countries are pending.

INDICATIONS
Repatha is a PCSK9 (proprotein convertase subtilisin/kexin type 9) inhibitor indicated:

• To reduce the risk of major adverse cardiovascular (CV) events (CV death, myocardial infarction, stroke, unstable angina requiring hospitalization, or coronary revascularization) in adults at increased risk for these events.
• As an adjunct to diet and exercise to reduce low-density lipoprotein cholesterol (LDL-C) in:
  • adults with hypercholesterolemia.
  • adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH).
  • adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH).

The safety and effectiveness of Repatha® have not been established in pediatric patients with HeFH or HoFH who are younger than 10 years old or in pediatric patients with other types of hyperlipidemia. For full prescribing information, visit www.Repatha.com.

Important U.S. Safety Information 

• Contraindication: Repatha^® is contraindicated in patients with a history of a serious hypersensitivity reaction to evolocumab or any of the excipients in Repatha^®. Serious hypersensitivity reactions including angioedema have occurred in patients treated with Repatha^®.
    
• Hypersensitivity Reactions: Hypersensitivity reactions, including angioedema, have been reported in patients treated with Repatha^®. If signs or symptoms of serious hypersensitivity reactions occur, discontinue treatment with Repatha^®, treat according to the standard of care, and monitor until signs and symptoms resolve.
    
• Adverse Reactions in Adults with Primary Hyperlipidemia: The most common adverse reactions (>5% of patients treated with Repatha^® and more frequently than placebo) were: nasopharyngitis, upper respiratory tract infection, influenza, back pain, and injection site reactions.
    
  From a pool of the 52-week trial and seven 12-week trials: Local injection site reactions 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. Hypersensitivity reactions occurred in 5.1% and 4.7% of Repatha^®-treated and placebo-treated patients, respectively. The most common hypersensitivity reactions were rash (1.0% versus 0.5% for Repatha^® and placebo, respectively), eczema (0.4% versus 0.2%), erythema (0.4% versus 0.2%), and urticaria (0.4% versus 0.1%).
    
• Adverse Reactions in the Cardiovascular Outcomes Trial: The most common adverse reactions (>5% of patients treated with Repatha^® and more frequently than placebo) were: diabetes mellitus (8.8% Repatha^®, 8.2% placebo), nasopharyngitis (7.8% Repatha^®, 7.4% placebo), and upper respiratory tract infection (5.1% Repatha^®, 4.8% placebo).
    
  Among the 16,676 patients without diabetes mellitus at baseline, the incidence of new-onset diabetes mellitus during the trial was 8.1% in patients treated with Repatha^® compared with 7.7% in patients that received placebo.
    
• Adverse Reactions in Pediatric Patients with HeFH: The most common adverse reactions (>5% of patients treated with Repatha^® and more frequently than placebo) were: nasopharyngitis, headache, oropharyngeal pain, influenza, and upper respiratory tract infection.
    
• Adverse Reactions in Adults and Pediatric Patients with HoFH: In a 12-week study in 49 patients, the adverse reactions that occurred in at least two patients treated with Repatha^® and more frequently than placebo were: upper respiratory tract infection, influenza, gastroenteritis, and nasopharyngitis. In an open-label extension study in 106 patients, including 14 pediatric patients, no new adverse reactions were observed.
    
• Immunogenicity: Repatha^® is a human monoclonal antibody. As with all therapeutic proteins, there is potential for immunogenicity with Repatha^®.

Please  see  full Prescribing Information. 

About Amgen
Amgen discovers, develops, manufactures and delivers innovative medicines to help millions of patients in their fight against some of the world's toughest diseases. More than 40 years ago, Amgen helped to establish the biotechnology industry and remains on the cutting-edge of innovation, using technology and human genetic data to push beyond what's known today. Amgen is advancing a broad and deep pipeline that builds on its existing portfolio of medicines to treat cancer, heart disease, osteoporosis, inflammatory diseases and rare diseases.

In 2024, Amgen was named one of the "World's Most Innovative Companies" by Fast Company and one of "America's Best Large Employers" by Forbes, among other external recognitions. 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 and Threads. 

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 BeOne Medicines Ltd. or Kyowa Kirin Co., Ltd.), the performance of Otezla^® (apremilast), our acquisitions of ChemoCentryx, Inc. or Horizon Therapeutics plc (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.

Our results may be affected by our ability to successfully market both new and existing products domestically and internationally, clinical and regulatory developments involving current and future products, sales growth of recently launched products, competition from other products including biosimilars, difficulties or delays in manufacturing our products and global economic conditions, including those resulting from geopolitical relations and government actions. In addition, sales of our products are affected by pricing pressure, political and public scrutiny and reimbursement policies imposed by third-party payers, including governments, private insurance plans and managed care providers and may be affected by regulatory, clinical and guideline developments and domestic and international trends toward managed care and healthcare cost containment. Furthermore, our research, testing, pricing, marketing and other operations are subject to extensive regulation by domestic and foreign government regulatory authorities. Our business may be impacted by government investigations, litigation and product liability claims. In addition, our business may be impacted by the adoption of new tax legislation or exposure to additional tax liabilities. Further, while we routinely obtain patents for our products and technology, the protection offered by our patents and patent applications may be challenged, invalidated or circumvented by our competitors, or we may fail to prevail in present and future intellectual property litigation. We perform a substantial amount of our commercial manufacturing activities at a few key facilities, including in Puerto Rico, and also depend on third parties for a portion of our manufacturing activities, and limits on supply may constrain sales of certain of our current products and product candidate development. An outbreak of disease or similar public health threat, and the public and governmental effort to mitigate against the spread of such disease, could have a significant adverse effect on the supply of materials for our manufacturing activities, the distribution of our products, the commercialization of our product candidates, and our clinical trial operations, and any such events may have a material adverse effect on our product development, product sales, business and results of operations. We rely on collaborations with third parties for the development of some of our product candidates and for the commercialization and sales of some of our commercial products. In addition, we compete with other companies with respect to many of our marketed products as well as for the discovery and development of new products. Further, some raw materials, medical devices and component parts for our products are supplied by sole third-party suppliers. Certain of our distributors, customers and payers have substantial purchasing leverage in their dealings with us. The discovery of significant problems with a product similar to one of our products that implicate an entire class of products could have a material adverse effect on sales of the affected products and on our business and results of operations. Our efforts to collaborate with or acquire other companies, products or technology, and to integrate the operations of companies or to support the products or technology we have acquired, may not be successful. There can be no guarantee that we will be able to realize any of the strategic benefits, synergies or opportunities arising from the Horizon acquisition, and such benefits, synergies or opportunities may take longer to realize than expected. We may not be able to successfully integrate Horizon, and such integration may take longer, be more difficult or cost more than expected. A breakdown, cyberattack or information security breach of our information technology systems could compromise the confidentiality, integrity and availability of our systems and our data. Our stock price is volatile and may be affected by a number of events. Our business and operations may be negatively affected by the failure, or perceived failure, of achieving our sustainability objectives. 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)
Adam Elinoff, 805-490-9578 (investors) 

References

1. Data on file, Amgen; 2024
2. Data on file, Amgen; 2024
3. Sabatine MS, et al. N Engl J Med. 2017;376:1713-1722

 

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SOURCE Amgen

FAQ

What price will Repatha (AMGN) cost through AmgenNow starting Oct 6, 2025?

Repatha will be offered at a monthly price of $239, nearly 60% below the current U.S. list price.

Who is eligible to buy Repatha via AmgenNow (AMGN)?

AmgenNow is open to all U.S. patients, including the uninsured, those with high-deductible plans, cash payers, and participants in Medicare and Medicaid.

Does using AmgenNow (AMGN) require insurer prior authorization or step therapy?

No; patients using AmgenNow are not subject to insurer step therapy or prior authorization.

What clinical evidence did Amgen cite for Repatha in the Oct 6, 2025 announcement?

The announcement cites VESALIUS-CV Phase 3 results showing Repatha significantly reduced major adverse cardiovascular events (MACE).

Is the AmgenNow Repatha price available outside the U.S. as of Oct 6, 2025?

The company said the new direct-to-patient price is the lowest among G-7 countries and is being offered exclusively to U.S. patients for the first time.

Where can patients find more information about Repatha through AmgenNow?

More information is available at www.amgensupportplus.com/patient/repatha.