Core Insights - Amgen announced that the Phase 3 VESALIUS-CV clinical trial of Repatha met its dual primary endpoints, demonstrating significant reduction in major adverse cardiovascular events (MACE) in high-risk patients without prior heart attack or stroke [2][3] - The results will be presented at the American Heart Association Scientific Sessions in November 2025, highlighting Repatha's position as a leading LDL-C lowering therapy [1][2] Group 1: Clinical Trial Results - The VESALIUS-CV trial is the first to show that Repatha significantly reduces the risk of MACE in individuals without a history of heart attack or stroke [2] - The trial's findings emphasize the importance of early intervention and maintaining low LDL-C levels to prevent cardiovascular events [2][3] Group 2: Real-World Evidence - Data from the VESALIUS-REAL global observational study, covering over 1.1 million patients across 11 countries, will provide insights into lipid management and MACE incidence in high-risk populations [3] - The REPATHA-CE trial, the largest real-world study of patients with established atherosclerotic cardiovascular disease (ASCVD), demonstrates Repatha's effectiveness in reducing MACE in clinical practice [4] Group 3: Company Commitment - Amgen is committed to advancing cardiovascular care through innovative treatments and extensive research, as evidenced by its ongoing clinical trials and real-world studies [2][7] - The company aims to address multiple interrelated risk factors associated with cardiovascular disease, reflecting a comprehensive approach to prevention and care [7]

Core Insights - Amgen has launched a new direct-to-patient program called AmgenNow, offering Repatha at a monthly price of $239, which is nearly 60% lower than the current U.S. list price [2][3] - The program aims to support patients, including those uninsured or with high-deductible health plans, making it easier for them to access Repatha, which has shown significant clinical benefits in reducing major adverse cardiovascular events [1][2] - Repatha is a PCSK9 inhibitor that has been studied for 15 years in over 50 clinical trials involving more than 57,000 patients, demonstrating its effectiveness in lowering LDL cholesterol levels [3][4] Pricing and Accessibility - The AmgenNow program is available to all Repatha patients, including those on government programs like Medicare and Medicaid, and does not require prior authorization or step therapy from insurers [2][3] - The new pricing structure positions Repatha as the lowest-priced option among economically developed G-7 countries, reflecting Amgen's commitment to making medications more accessible [2][3] Clinical Background - Repatha works by inhibiting PCSK9, which allows for increased recycling of LDL receptors, thereby lowering LDL cholesterol levels in the blood [3] - The drug is approved in over 74 countries, including the U.S., Japan, Canada, and all EU member states, with applications pending in other regions [4] Indications and Safety Information - Repatha is indicated for adults and pediatric patients aged 10 years and older with specific types of hypercholesterolemia, and it is used as an adjunct to diet and exercise [7] - Important safety information includes contraindications for patients with a history of serious hypersensitivity reactions to evolocumab, and common adverse reactions reported include nasopharyngitis and upper respiratory tract infections [6][8]

Core Viewpoint - A federal court jury found Amgen liable for antitrust violations, awarding Regeneron $135.6 million in compensatory damages and $271.2 million in punitive damages due to Amgen's anticompetitive practices that hindered competition for Praluent [1][3]. Summary by Relevant Sections Antitrust Violations - Amgen was found to have violated multiple laws, including the Clayton Act and Sherman Act, by using cross-therapeutic bundled rebates to favor Repatha over Praluent, thereby preventing fair competition [1][2]. Jury Verdict and Damages - The jury awarded Regeneron a total of $406.8 million, comprising $135.6 million in compensatory damages and $271.2 million in punitive damages aimed at deterring similar future conduct [3]. Company Statements - Regeneron emphasized the importance of fair competition in the biotech industry, stating that anticompetitive tactics undermine patient access to innovative therapies and hinder medical advancements [4]. Product Information - Praluent, developed by Regeneron and Sanofi, is designed to lower LDL cholesterol levels by inhibiting PCSK9, and is approved in 60 countries [6][7]. Technology and Innovation - Regeneron's proprietary VelocImmune technology has been instrumental in developing fully human monoclonal antibodies, contributing to a significant portion of FDA-approved treatments [8][9].