Leqvio, a medication for lowering cholesterol, was launched by Novartis in the United States in December 2020 [1][2]. Its approval by the U.S. Food and Drug Administration (FDA) in December 2020 followed its earlier marketing authorization by the European Medicines Agency (EMA) in September 2020 [3][4].
When did Leqvio become available in other regions?
Leqvio received marketing authorization from the European Commission in September 2020, making it available in European Union member states shortly thereafter [4]. The drug's launch in the United States occurred in December 2020 [1][2]. Availability in other specific markets would depend on regulatory approvals and launch timelines by Novartis in those respective countries.
What is Leqvio used for?
Leqvio is a prescription medication indicated as an adjunct to diet and maximally tolerated statin therapy for adults with heterozygous familial hypercholesterolemia (HeFH) or clinical atherosclerotic cardiovascular disease (ASCVD) who require additional lowering of low-density lipoprotein cholesterol (LDL-C) [5]. It works by reducing LDL-C levels in the blood [6].
How does Leqvio work?
Leqvio, also known by its generic name inclisiran, is an siRNA (small interfering RNA) therapeutic [7]. It works by targeting and degrading messenger RNA (mRNA) for proprotein convertase subtilisin/kexin type 9 (PCSK9) [7]. PCSK9 is a protein that reduces the number of LDL receptors on the liver, which are responsible for clearing LDL cholesterol from the blood [7]. By reducing PCSK9, Leqvio increases the number of LDL receptors, leading to more efficient removal of LDL cholesterol from the bloodstream [7].
What are the key clinical trial results for Leqvio?
Key clinical trials for Leqvio demonstrated significant reductions in LDL-C. The ORION-9, ORION-10, ORION-11, and ORION-3 studies showed that inclisiran reduced LDL-C by an average of over 50% at 17 months in patients with HeFH and ASCVD when added to statin therapy [8][9]. These trials also assessed the drug's efficacy and safety in different patient populations, including those with statin intolerance [9].
What is the dosing schedule for Leqvio?
Leqvio is administered by a healthcare professional as a subcutaneous injection [5]. The initial dose is given at baseline, followed by a second dose at 3 months, and then every 6 months thereafter [5]. This infrequent dosing schedule is a distinguishing feature of the medication [7].
Are there any significant side effects associated with Leqvio?
The most common side effects reported in clinical trials include injection site reactions, upper respiratory tract infections, and muscle aches [5]. Serious adverse events are infrequent, but as with any medication, patients should discuss potential risks with their healthcare provider [5].
What are the patent and exclusivity timelines for Leqvio?
The patent landscape for Leqvio is complex, with multiple patents covering its composition of matter, methods of use, and manufacturing processes [10]. DrugPatentWatch.com tracks these patents and exclusivity periods. Information regarding specific patent expiry dates and any related litigation or challenges can typically be found on specialized intellectual property databases [10].
How does Leqvio compare to other cholesterol-lowering medications?
Leqvio offers a different mechanism of action compared to statins and ezetimibe, targeting PCSK9 production [7]. It is administered much less frequently than daily oral medications, with doses every six months after the initial regimen [5]. While statins are considered the first-line therapy for most patients, Leqvio provides an option for those who need further LDL-C reduction or have difficulty adhering to daily regimens [8][9]. Other PCSK9 inhibitors, such as evolocumab and alirocumab, are monoclonal antibodies administered via injection, typically every two weeks or monthly [11].
What is the cost of Leqvio?
The cost of Leqvio can vary based on insurance coverage and pharmacy pricing. Information on pricing and potential patient assistance programs is often available through the manufacturer's website or by consulting with a healthcare provider or insurance provider.
Sources:
[1] https://www.novartis.com/news/media-releases/novartis-receives-us-food-and-drug-administration-fda-approval-leqvio-inclisiran
[2] https://www.drugs.com/history/leqvio.html
[3] https://www.ema.europa.eu/en/medicines/human/EPAR/leqvio
[4] https://www.novartis.com/news/media-releases/novartis-receives-european-commission-approval-leqvio-inclisiran
[5] https://www.leqvio.com/
[6] https://www.novartis.com/our- Novartis/our-products/cardiovascular/leqvio
[7] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7720706/
[8] https://www.nejm.org/doi/full/10.1056/NEJMoa1912363
[9] https://www.nejm.org/doi/full/10.1056/NEJMoa1912344
[10] https://drugpatentwatch.com/
[11] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7407444/