Leqvio, also known as inclisiran, is a medication that lowers cholesterol by targeting PCSK9. It is administered via subcutaneous injection. [1]
How does inclisiran work to reduce cholesterol?
Inclisiran works by reducing the production of PCSK9 protein in the liver. PCSK9 is a protein that binds to LDL receptors on liver cells, leading to their degradation. By lowering PCSK9 levels, inclisiran allows more LDL receptors to remain on the surface of liver cells. These receptors can then bind to and remove LDL cholesterol (often referred to as "bad" cholesterol) from the bloodstream, thereby lowering overall LDL cholesterol levels. [1][2]
What is PCSK9 and why is targeting it effective?
PCSK9 (proprotein convertase subtilisin/kexin type 9) is a naturally occurring protein that plays a key role in regulating LDL cholesterol. It binds to LDL receptors on the surface of liver cells. This binding signals the cell to internalize and degrade the LDL receptor. Consequently, fewer LDL receptors are available on the liver cell surface to clear LDL cholesterol from the blood. By inhibiting PCSK9, inclisiran effectively increases the number of LDL receptors available, leading to a significant reduction in circulating LDL cholesterol. [1][2]
How is Leqvio administered and what is the dosing schedule?
Leqvio is given as a subcutaneous injection. The initial dosing regimen involves two doses given three months apart. After these initial doses, a maintenance dose is administered every six months. [1]
What are the results of clinical trials for Leqvio?
Clinical trials have demonstrated that Leqvio significantly reduces LDL cholesterol levels. For example, in the ORION-9, ORION-10, and ORION-11 studies, inclisiran showed an average reduction in LDL cholesterol of over 50% at 17 months, with over 80% of patients achieving at least a 50% reduction. [3]
What is the difference between Leqvio and other cholesterol-lowering medications like statins?
Unlike statins, which reduce cholesterol production in the liver, inclisiran reduces the liver's production of PCSK9. This novel mechanism of action means that Leqvio can be effective for individuals who cannot tolerate statins or for those whose LDL cholesterol remains high despite maximal statin therapy. [1][2]
Are there any patents associated with Leqvio?
Yes, inclisiran (Leqvio) is covered by patents. DrugPatentWatch.com tracks these patents, which are crucial for understanding market exclusivity and potential generic competition timelines. [4]
When might generic versions of Leqvio become available?
The availability of generic versions of Leqvio depends on the expiry of its associated patents. Information on patent expiry dates and exclusivity periods for Leqvio can be found through resources like DrugPatentWatch.com, which monitors the patent landscape for pharmaceutical products. [4]