PraluentEdit
Praluent, the brand name for alirocumab, is a monoclonal antibody that targets PCSK9 (proprotein convertase subtilisin/kexin type 9). By inhibiting PCSK9, Praluent increases the number of LDL (low-density lipoprotein) receptors on liver cells, boosting the clearance of LDL cholesterol from the bloodstream. Developed by Regeneron and Sanofi, it was approved in 2015 by the U.S. Food and Drug Administration for adults with heterozygous familial hypercholesterolemia (familial hypercholesterolemia) or clinical atherosclerotic cardiovascular disease who require additional lowering of LDL-C in addition to diet and maximally tolerated statin therapy, or in patients who are statin-intolerant. Praluent is administered by subcutaneous injection and can be given every two weeks or, for some regimens, every four weeks, at doses such as 75 mg or 150 mg every two weeks, with a monthly option of 300 mg in certain circumstances.
Mechanism of action
Praluent belongs to the class of PCSK9 inhibitors. By binding circulating PCSK9, it prevents PCSK9 from binding to LDL receptors on hepatocytes, reducing receptor degradation. This preserves LDL receptors, increasing hepatic uptake of LDL-C and thereby lowering circulating LDL levels. The mechanism is complementary to statins, which upregulate LDL receptors by reducing cholesterol synthesis; in combination, Praluent and statins can achieve substantially lower LDL-C than statins alone. See also PCSK9 for the broader scientific context.
Clinical use and dosing
Praluent is indicated for adults with HeFH or ASCVD who require additional LDL-C lowering beyond what is achieved with diet and maximally tolerated statin therapy, or for patients who are statin-intolerant. Pediatric use has been studied and approved for certain patients aged 10 years and older with FH or ASCVD in some regulatory jurisdictions.
Dosing regimens commonly used include 75 mg every two weeks, with the option to increase to 150 mg every two weeks if target LDL-C reductions are not reached; alternatively, a 300 mg monthly dose can be used in eligible patients. Dosing decisions consider baseline LDL-C, prior therapies, and patient tolerance.
In practice, Praluent is typically added to background lipid-lowering therapy, and clinicians monitor LDL-C response and adverse effects to guide dose adjustments. For background reading on lipid disorders and standard treatments, see Hyperlipidemia and statins.
Efficacy and outcomes
Clinical trials demonstrated substantial reductions in LDL-C with Praluent, commonly in the range of 50–60 percent when added to statin therapy in patients with high baseline LDL-C. In addition to LDL-C lowering, major cardiovascular outcomes trials have shown reductions in some cardiovascular events among high-risk patients, though results on all-cause mortality have been more nuanced and depend on patient populations and study design. Trials of Praluent and other PCSK9 inhibitors have contributed to a broader shift in lipid management toward aggressive LDL-C targets in high-risk groups, while also highlighting questions about long-term outcomes and durability of benefit across diverse populations. See also ODYSSEY OUTCOMES for randomized trial data on alirocumumab in certain post-ACS populations, and Repatha (evolocumab) for related evidence in a parallel inhibitor class.
Safety and adverse effects
Commonly reported adverse events include injection-site reactions, nasopharyngitis, flu-like symptoms, and upper respiratory infections. Rare but monitored adverse effects have included neurocognitive events in some clinical studies, leading to labeling language about potential cognitive effects while preserving overall favorable lipid-lowering safety. As with any biologic therapy, clinicians assess risks and benefits on an individual basis, particularly in patients with complex cardiovascular risk profiles.
Economics, access, and policy considerations
The price and reimbursement landscape for Praluent has been a focal point in debates about value-based care, healthcare costs, and innovation incentives. The drug carries a premium price relative to many traditional lipid-lowering therapies, and payers have sought price concessions, preferred-use criteria, and, in some cases, outcomes-based contracts in exchange for coverage. Cost-effectiveness analyses have often found the therapy more justifiable in select high-risk patients with suboptimal LDL-C targets despite maximized statin therapy, rather than as a broad, indiscriminate prescription across all patients with elevated LDL-C. This has led to step therapy approaches in some insurer formularies and to discussions about patient access versus budgetary constraints in a system that funds extensive cardiovascular care.
From a policy perspective, the core question is how to balance encouraging medical innovation with ensuring responsible use of finite health resources. Proponents of market-based approaches contend that price discipline, payer negotiations, and demonstrated real-world value should govern access, while critics argue for broader government-led price negotiations or subsidies to guarantee wider patient access. In this framing, Praluent is often cited in broader debates about the cost of breakthrough therapies and the role of private sector incentives in delivering high-cost precision medicines. In this context, some critics of expansive access argue that the costs of such drugs should not be borne broadly by taxpayers or insurers without clear, demonstrable long-term health gains. Conversely, supporters note that preventing costly cardiovascular events can yield downstream savings in hospitalizations and procedures and may improve quality of life for high-risk patients.
In the public discourse surrounding drug pricing, the conversation around Praluent has also touched on how best to encourage innovation while maintaining affordability. Advocates for limited government price intervention emphasize market dynamics, risk-sharing agreements with manufacturers, and selective coverage for patients most likely to benefit, arguing that broad, indiscriminate funding for high-cost therapies can crowd out other effective interventions. Critics of such positions may frame the debate in terms of distributive fairness, but from a policy and budgeting standpoint, many health systems prioritize treatments with proven, durable outcomes in high-risk populations when evaluating coverage decisions.
See also discussions of related therapies and concepts, including PCSK9, LDL, statins, and other lipid-lowering strategies such as Evolocumab (Repatha) and emerging approaches like inclisiran.