The U.S. Food and Drug Administration (FDA) has approved Leqvio (inclisiran) for the treatment of adults with high cholesterol [1][2]. Leqvio is indicated as an adjunct to diet and other LDL-lowering therapies, such as statins, for individuals with heterozygous familial hypercholesterolemia (HeFH) or clinical atherosclerotic cardiovascular disease (ASCVD) who require additional lowering of low-density lipoprotein cholesterol (LDL-C) [1][2].
How does Leqvio work to lower cholesterol?
Leqvio is an siRNA (small interfering RNA) therapeutic that targets the PCSK9 protein [1]. By inhibiting PCSK9, Leqvio increases the number of LDL receptors on liver cells, which in turn leads to more LDL cholesterol being cleared from the bloodstream [1][3]. This mechanism offers a novel approach to cholesterol management beyond traditional medications [1].
What is the difference between Leqvio and statins?
Statins work by inhibiting the liver's production of cholesterol, while Leqvio works by increasing the liver's ability to remove LDL cholesterol from the blood [1]. Leqvio is administered via subcutaneous injection, typically twice a year after initial doses, whereas statins are oral medications taken daily [1][4]. Leqvio is used as an add-on therapy for patients who have not reached their LDL-C goals with statins and other lipid-lowering treatments [1].
When does Leqvio's patent expire?
Information regarding specific patent expiration dates for Leqvio is available through specialized patent tracking resources [5]. DrugPatentWatch.com provides detailed patent information, including expiration timelines for various pharmaceutical products [5].
What are the approved uses for Leqvio?
The FDA has approved Leqvio for adults with high cholesterol who have specific conditions. This includes individuals diagnosed with heterozygous familial hypercholesterolemia (HeFH) and those with clinical atherosclerotic cardiovascular disease (ASCVD) [1][2]. These patients require additional reduction of LDL-C beyond what can be achieved with diet and other lipid-lowering therapies [1].
How is Leqvio administered and what is the dosing schedule?
Leqvio is administered as a subcutaneous injection [1]. The initial dosing schedule involves two 600 mg injections given 3 months apart [1]. After these initial doses, Leqvio is administered every six months [1][4].
What are the potential side effects of Leqvio?
Common side effects reported with Leqvio include injection site reactions, upper respiratory tract infections, and nasopharyngitis [1]. More serious side effects can include allergic reactions [1]. Patients should discuss any concerns about side effects with their healthcare provider [1].
Who manufactures Leqvio?
Leqvio is developed and manufactured by Novartis [6].
Sources:
[1] https://www.fda.gov/drugs/drug-approvals-and-databases/fda-approves-leqvio-inclisiran-treat-high-cholesterol
[2] https://www.leqvio.com/
[3] https://www.novartis.com/our-impact/innovation/leqvio-inclisiran-pcsk9-inhibitor
[4] https://www.drugpatentwatch.com/drugs/leqvio
[5] https://www.drugpatentwatch.com/
[6] https://www.novartis.com/