Praluent manufacturer
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Praluent Manufacturer: Regeneron Pharmaceuticals and Sanofi
Introduction to Praluent (Alirocumab)
Praluent, also known by its generic name alirocumab, is a fully human monoclonal antibody developed collaboratively by Regeneron Pharmaceuticals and Sanofi. It has been approved by the FDA 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 cholesterol (LDL-C) .
Mechanism of Action: PCSK9 Inhibition
Praluent works by specifically binding to proprotein convertase subtilisin/kexin type 9 (PCSK9), a protein that downregulates liver LDL receptors. By inhibiting PCSK9, Praluent increases the liver's ability to remove LDL-C from the blood, thereby significantly reducing LDL-C levels .
Clinical Efficacy and Approval
Praluent has demonstrated significant efficacy in reducing LDL-C levels in various patient populations, including those with HeFH and nonfamilial hypercholesterolemia. Clinical trials have shown that it is effective both as a monotherapy and in combination with statin therapy, providing sustained LDL-C-lowering effects over long-term treatment periods. The FDA approved Praluent on July 24, 2015, marking it as the first PCSK9 inhibitor to receive approval in the United States .
Legal and Market Dynamics
The development and market introduction of Praluent have not been without challenges. Amgen, another pharmaceutical company, holds patents for monoclonal antibodies against PCSK9 and has engaged in legal battles with Regeneron and Sanofi over patent infringement claims. Despite these legal issues, Praluent remains available to physicians and patients, although Amgen has sought a permanent injunction to limit its sales.
Competitive Landscape
Praluent faces competition from other PCSK9 inhibitors, most notably Amgen's Repatha (evolocumab). Both drugs were approved around the same time and are part of a new class of cholesterol-lowering medications that have shown to be more potent than traditional statins . The competition between these drugs has intensified the focus on the market for PCSK9 inhibitors, which is expected to be highly lucrative.
Conclusion
Praluent, developed by Regeneron Pharmaceuticals and Sanofi, represents a significant advancement in the treatment of hypercholesterolemia, particularly for patients who do not achieve adequate LDL-C reduction with statins alone. Despite facing legal challenges and competition, Praluent continues to be a valuable option for managing high cholesterol levels, offering a new mechanism of action through PCSK9 inhibition.
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