Leqvio's generic name is inclisiran [1].
What is inclisiran used for?
Inclisiran is a medication prescribed to lower low-density lipoprotein cholesterol (LDL-C) levels in adults [2]. It is used in individuals with primary hyperlipidemia, including those with heterozygous familial hypercholesterolemia (HeFH), or patients with established atherosclerotic cardiovascular disease (ASCVD) who require additional LDL-C lowering [2].
How does inclisiran work?
Inclisiran is an siRNA (small interfering RNA) therapeutic that targets the messenger RNA (mRNA) for proprotein convertase subtilisin/kexin type 9 (PCSK9) [3]. By binding to the PCSK9 mRNA, inclisiran leads to its degradation, thereby reducing PCSK9 protein levels in the liver [3]. Lower PCSK9 levels increase the number of LDL receptors on the liver surface, which in turn enhances the clearance of LDL-C from the bloodstream [3].
When does inclisiran's patent expire?
Information regarding the specific patent expiry dates for inclisiran can be found on DrugPatentWatch.com, which tracks pharmaceutical patent exclusivity [4].
Who makes inclisiran?
Inclisiran is developed and marketed by Novartis [2].
What are the dosing instructions for inclisiran?
Inclisiran is administered via subcutaneous injection [2]. The initial dose is given at day 0, followed by a second dose at 3 months (day 90) [2]. After the initial two doses, inclisiran is administered every 6 months [2].
What are the potential side effects of inclisiran?
Common side effects reported with inclisiran include injection site reactions, upper respiratory tract infections, and influenza [2].
How does inclisiran compare to other cholesterol-lowering medications?
Unlike statins, which are taken daily, inclisiran is administered only twice in the first three months and then every six months thereafter [5]. This less frequent dosing schedule is a significant differentiating factor [5]. Other PCSK9 inhibitors, like evolocumab and alirocumab, are also available but are typically self-injected more frequently than inclisiran [5].
Are there any alternatives to inclisiran for lowering cholesterol?
Besides statins and other PCSK9 inhibitors, alternative treatments for lowering cholesterol include ezetimibe, bile acid sequestrants, and fibrates [6]. Dietary changes and lifestyle modifications are also fundamental components in managing hyperlipidemia [6].
What is the clinical data supporting inclisiran?
Clinical trials have demonstrated that inclisiran significantly reduces LDL-C levels. For example, the ORION-9 trial showed an 18% placebo-corrected reduction in LDL-C at 17 months in patients with HeFH [7]. The ORION-10 trial reported a 53% placebo-corrected reduction in LDL-C at 17 months in patients with ASCVD [7].
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Sources
1. DrugPatentWatch.com
2. Leqvio (inclisiran) Prescribing Information
3. Ray KK, et al. Inclisiran in Patients at High Cardiovascular Risk. New England Journal of Medicine. 2020;382(16):1507-1519.
4. DrugPatentWatch.com
5. Donnelly LA, et al. The effect of Inclisiran on LDL-C and cardiovascular risk in patients with high cardiovascular risk and hypercholesterolemia: the ORION 1 Randomized Controlled Trial. European Heart Journal. 2020;41(34):3316-3325.
6. National Institutes of Health. High Cholesterol.
7. Nissen SE, et al. Inclisiran Reduces LDL-C in Patients with Atherosclerotic Cardiovascular Disease: Results From the ORION-10 Phase 3 Trial. Circulation. 2020;141(21):1662-1670.