Repatha® – Evolocumab Injection

Repatha® – Evolocumab Injection | U.S.-Manufactured Global Supply PCSK9 Monoclonal Antibody

Product Overview

Repatha® (evolocumab) is a fully human monoclonal antibody (IgG2) developed by Amgen Inc., specifically designed to inhibit proprotein convertase subtilisin/kexin type 9 (PCSK9) — a protein that degrades LDL receptors in the liver. By blocking PCSK9, Repatha® increases LDL receptor availability and significantly lowers low-density lipoprotein cholesterol (LDL-C) in patients at high risk of cardiovascular events.

The product offered here is manufactured in the United States and supplied through Amgen’s global distribution chain, intended for international markets under local regulatory compliance. While packaging and labeling are adapted for destination countries, the formulation, device, and therapeutic equivalence are identical to the U.S.-marketed version.

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Key Features & Advantages

• ✅ Made in the U.S.A. by Amgen
  Manufactured under full FDA and cGMP compliance; distributed globally under originator control.

• ✅ First-in-Class PCSK9 Inhibitor
  Proven to dramatically lower LDL-C by up to 60% when combined with statin therapy.

• ✅ Same Formulation as U.S. Version
  Only outer packaging and label language vary depending on regulatory requirements.

• ✅ Approved in 100+ Countries
  Indicated for high-risk cardiovascular patients with hyperlipidemia, familial hypercholesterolemia, and statin intolerance.

• ✅ Ready for Global Institutional Supply
  Trusted in leading hospitals and heart institutes worldwide.

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Product Specifications

• Product Name: Repatha® (evolocumab injection)

• Active Ingredient: Evolocumab (recombinant human IgG2 monoclonal antibody)

• Strength / Form: 140 mg/mL prefilled syringe or SureClick® autoinjector

• Route of Administration: Subcutaneous injection

• Manufacturer: Amgen Inc. (USA)

• Packaging: Destination-specific language (e.g., English, Chinese, Spanish); formulation identical across markets

• Storage: Refrigerated at 2°C–8°C; do not freeze

• Shelf Life: Typically 18–24 months from manufacture

• Distribution Type: Original brand biologic; not a biosimilar

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Mechanism of Action

Repatha® works by binding to PCSK9, a protein that downregulates LDL receptors (LDL-R) on hepatocytes. Inhibiting PCSK9 increases the number of LDL-R available to remove LDL-C from the bloodstream, effectively lowering “bad cholesterol” levels.

Clinical trials (e.g., FOURIER study) have demonstrated:

• Up to 60% LDL-C reduction on top of statin therapy

• Reduction in risk of major cardiovascular events (MI, stroke)

• Efficacy in patients with familial hypercholesterolemia

For more: NIH PCSK9 & Evolocumab Overview

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Indications (may vary by country)

• Primary hyperlipidemia including heterozygous familial hypercholesterolemia (HeFH)

• Homozygous familial hypercholesterolemia (HoFH)

• Established atherosclerotic cardiovascular disease (ASCVD) in high-risk patients

• Statin-intolerant hypercholesterolemia (as approved)

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Compliance Statement

This product is manufactured in the United States by Amgen Inc. and is distributed as part of the company’s global pharmaceutical supply chain. The formulation, device, and quality are identical to the U.S.-marketed version. Packaging language may vary to meet destination market regulations. This product is not a biosimilar. All importers and users are responsible for compliance with local health authority requirements and licensing conditions.

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Tags / Keywords

Repatha, Evolocumab Injection, PCSK9 Inhibitor, LDL Cholesterol Lowering Antibody, Amgen Monoclonal Antibody, Hypercholesterolemia Therapy, Cardiovascular Risk Reduction Biologic, U.S.-Manufactured Repatha, Global Supply Chain MAb, Non-Biosimilar Lipid Therapy