REPATHA® NOW INDICATED FOR ADULTS AT INCREASED RISK FOR MAJOR ADVERSE CARDIOVASCULAR EVENTS DUE TO UNCONTROLLED LDL-C

Core Insights - The FDA has expanded the approved use of Repatha® (evolocumab) to include adults at increased risk for major adverse cardiovascular events (MACE) due to uncontrolled low-density lipoprotein cholesterol (LDL-C), removing the previous requirement for a cardiovascular disease diagnosis [1][2] - Repatha is recognized as an effective therapy for lowering LDL-C, especially for patients who are statin-resistant or intolerant [2] - Repatha has been used by over 5 million people globally since its initial approval in 2015 [2] Company Overview - Amgen is a biotechnology company that focuses on discovering, developing, manufacturing, and delivering innovative medicines for serious diseases [10] - The company has been recognized as one of the "World's Most Innovative Companies" and is part of the Dow Jones Industrial Average and Nasdaq-100 Index [11] Product Information - Repatha is a human monoclonal antibody that inhibits PCSK9, leading to increased LDL receptors and reduced LDL-C levels [3] - The clinical safety and efficacy of Repatha have been validated through 15 years of research involving over 57,000 patients across 50 clinical trials [3] Regulatory Status - Repatha is approved in over 74 countries, including the U.S., Japan, Canada, and all EU member states, with additional applications pending in other regions [4] Safety and Efficacy - Common adverse reactions reported in clinical trials include nasopharyngitis, upper respiratory tract infections, and injection site reactions, with hypersensitivity reactions occurring in 5.1% of patients treated with Repatha [9][14] - The most common adverse reactions in the cardiovascular outcomes trial included diabetes mellitus and upper respiratory tract infections [9]