Who makes repatha
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Summary
4 papers analyzed
These studies suggest that Repatha is the brand name for evolocumab, a cholesterol-lowering medication developed for certain high-risk patients.
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Beta20 papers analyzed
Manufacturer of Repatha: Amgen
Introduction to Repatha (Evolocumab)
Repatha, also known by its generic name evolocumab, is a fully human monoclonal antibody designed to lower cholesterol levels. It specifically targets and binds to proprotein convertase subtilisin/kexin type 9 (PCSK9), a protein that negatively regulates low-density lipoprotein (LDL) receptors. By inhibiting PCSK9, Repatha enhances the liver's ability to remove LDL cholesterol from the blood, thereby reducing overall LDL-C levels.
Development and Approval
Global Approval and Usage
Repatha was developed by Amgen and has received approval for use in various regions, including the European Union, the United States, and Japan. It is indicated for the treatment of adults with primary hypercholesterolemia (both heterozygous familial and non-familial) or mixed dyslipidemia, either as a monotherapy or in combination with statins and other lipid-lowering therapies. Additionally, it is approved for use in adults and adolescents aged 12 years and older with homozygous familial hypercholesterolemia.
FDA Approval
In the United States, the FDA has approved Repatha as an adjunct to diet and maximally tolerated statin therapy for adults with heterozygous familial hypercholesterolemia (HeFH) or clinical atherosclerotic cardiovascular disease who require additional lowering of LDL-C. It is also approved for patients with homozygous familial hypercholesterolemia (HoFH) who need further LDL-C reduction. The FDA's Endocrinologic and Metabolic Drugs Advisory Committee recommended its approval with a unanimous vote, highlighting its efficacy and safety profile.
Cost Considerations
Cost-Effectiveness
Despite its clinical benefits, the cost of Repatha has been a point of contention. Studies have indicated that for Repatha to be considered cost-effective, its price would need to be significantly reduced. One study suggested that the price would need to be cut by more than two-thirds to meet a cost-effectiveness threshold of $100,000 per quality-adjusted life year (QALY). This has led to ongoing discussions about the pricing strategies for this medication to ensure broader accessibility and affordability.
Conclusion
Repatha, developed by Amgen, is a significant advancement in the treatment of hypercholesterolemia, offering substantial LDL-C reduction for patients with various forms of familial hypercholesterolemia and clinical atherosclerotic cardiovascular disease. While its clinical efficacy is well-documented and supported by regulatory approvals, the high cost remains a barrier to its widespread use, necessitating discussions on pricing to enhance its cost-effectiveness and accessibility.
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