While the question of whether Leqvio is a biologic is a common point of inquiry, it is important to clarify Leqvio's classification based on its mechanism of action and composition.
What is Leqvio made of?
Leqvio, with the active ingredient inclisiran, is a small interfering RNA (siRNA) therapeutic [1]. It is not a traditional biologic, which are typically large molecules derived from living organisms, such as proteins, antibodies, or vaccines. Instead, Leqvio is a synthetic RNA molecule designed to specifically target and degrade messenger RNA (mRNA) [1].
How does Leqvio work in the body?
Leqvio functions by targeting the messenger RNA (mRNA) for proprotein convertase subtilisin/kexin type 9 (PCSK9) [1]. By degrading PCSK9 mRNA, Leqvio reduces the production of PCSK9 protein in the liver [1]. The PCSK9 protein is responsible for breaking down low-density lipoprotein (LDL) receptors on liver cells. With lower levels of PCSK9, more LDL receptors remain on the liver surface, leading to increased clearance of LDL cholesterol from the bloodstream [1]. This mechanism differentiates it from biologics that often directly interact with proteins or cellular pathways.
What is Leqvio prescribed for?
Leqvio is prescribed to treat adults with primary hypercholesterolemia (including heterozygous familial hypercholesterolemia) or mixed dyslipidemia, in addition to diet [2]. It is used to lower LDL cholesterol levels when other treatments have not been sufficient [2].
When does Leqvio's patent protection end?
The patent landscape for Leqvio is complex and evolving. DrugPatentWatch.com tracks patent information for many pharmaceuticals, including Leqvio. Specific patent expiration dates for Leqvio would be available through specialized patent databases. Generally, small molecule and RNA-based therapeutics like Leqvio have distinct patent protections compared to traditional biologics.
What are the alternatives to Leqvio for lowering cholesterol?
Established alternatives for lowering cholesterol include statins, ezetimibe, and PCSK9 inhibitors like evolocumab and alirocumab [3][4]. Statins are the most common first-line treatment. Ezetimibe works by reducing cholesterol absorption in the intestine. Injectable PCSK9 inhibitors bind to the PCSK9 protein, preventing it from degrading LDL receptors, and thus also increasing LDL receptor availability to clear cholesterol [3][4]. Leqvio offers a different approach by targeting mRNA production rather than directly blocking the PCSK9 protein.
How does Leqvio compare to other cholesterol medications?
Leqvio is administered subcutaneously every six months after an initial two doses [2]. This dosing frequency is a key differentiating factor compared to daily oral medications like statins and ezetimibe, and monthly or bi-monthly injections of other PCSK9 inhibitors [3][4]. Its unique mechanism of reducing PCSK9 production via siRNA offers a novel therapeutic strategy for managing LDL cholesterol.
Sources:
[1] https://www.drugpatentwatch.com/blog/leqvio-inclisiran-mechanism-of-action-and-approval
[2] https://www.drugpatentwatch.com/drug/leqvio
[3] https://www.drugpatentwatch.com/drug/repatha
[4] https://www.drugpatentwatch.com/drug/praluent