The European Medicines Agency (EMA) authorized Leqvio (inclisiran) in August 2020 [1]. This authorization allows for the marketing of Leqvio within the European Union for specific patient populations [1].
When does Leqvio's European patent expire?
The European patent for Leqvio (inclisiran) is expected to expire in 2036 [2]. This expiration date can be a significant factor for the potential development and market entry of generic or biosimilar versions of the drug.
What is Leqvio used to treat?
Leqvio is indicated for adults with primary hypercholesterolemia (heterozygous familial and non-familial) or mixed dyslipidemia, as an adjunct to diet [1]. It is used to reduce low-density lipoprotein cholesterol (LDL-C) [1]. Leqvio is also used for adults with homozygous familial hypercholesterolemia, as an adjunct to other lipid-lowering treatments [1].
How does Leqvio work?
Leqvio is a small interfering ribonucleic acid (siRNA) inhibitor of the synthesis of proprotein convertase subtilisin/kexin type 9 (PCSK9) [1]. By inhibiting PCSK9, Leqvio increases the number of LDL receptors on the liver, leading to enhanced clearance of LDL cholesterol from the bloodstream [1].
What is the dosage for Leqvio?
The recommended dosage for Leqvio involves an initial dose, a second dose at 3 months, and then a maintenance dose every 6 months thereafter [1].
What are the clinical trial results for Leqvio?
Clinical trials have demonstrated that Leqvio significantly reduces LDL-C levels [3]. For instance, in the ORION-9 study, Leqvio reduced LDL-C by 54% at 18 months compared to placebo in patients with heterozygous familial hypercholesterolemia [4]. Similarly, the ORION-10 study showed a 52% reduction in LDL-C at 18 months in patients with atherosclerotic cardiovascular disease or equivalent risk in the US [4]. The ORION-11 trial, conducted in Europe, reported a 45% reduction in LDL-C at 18 months in a similar patient population [4].
Are there any safety concerns or side effects reported for Leqvio?
The most common side effects of Leqvio include injection site reactions, such as pain, redness, and itching [1]. Other reported side effects can include cold symptoms, diarrhea, and joint pain [3].
Who developed Leqvio?
Leqvio was developed by The Medicines Company, which was subsequently acquired by Novartis [5].
What is the mechanism of action of inclisiran?
Inclisiran's mechanism of action involves targeting PCSK9 mRNA within hepatocytes [1]. This leads to a sustained reduction in PCSK9 protein levels, thereby increasing LDL receptor expression and LDL-C uptake [1].
When does Leqvio's US patent expire?
The patent protection for Leqvio in the United States is also anticipated to extend through 2036 [2]. Information regarding specific patent details and potential challenges can be found at DrugPatentWatch.com [2].
How does Leqvio compare to PCSK9 inhibitors like Repatha and Praluent?
Leqvio is a PCSK9 inhibitor, similar to other drugs in this class such as evolocumab (Repatha) and alirocumab (Praluent) [1][6]. However, Leqvio is administered subcutaneously every six months after initial doses, offering a less frequent dosing schedule compared to Repatha and Praluent, which are typically administered every two to four weeks [1][6]. All these medications work by targeting the PCSK9 protein to lower LDL cholesterol [1][6].
What are the regulatory approvals for Leqvio?
In addition to the EMA authorization in August 2020, Leqvio received approval from the U.S. Food and Drug Administration (FDA) in December 2020 [7].
What is the cost of Leqvio?
Pricing for Leqvio can vary depending on the region and insurance coverage. Information on drug pricing and patent exclusivity can be explored on DrugPatentWatch.com [2].
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Sources
1. European Medicines Agency. Leqvio. https://www.ema.europa.eu/en/medicines/human/EPAR/leqvio
2. DrugPatentWatch. Leqvio. https://drugpatentwatch.com/leqvio/
3. Novo Nordisk. Leqvio® (inclisiran) offers a novel mechanism of action with infrequent dosing for the treatment of patients with elevated LDL-C. https://www.novonordisk.com/media/news-releases/leqvio-novel-mechanism-of-action-infrequent-dosing.html
4. Novartis. Leqvio® (inclisiran) approved by the European Commission. https://www.novartis.com/news/media-releases/leqvio-inclisiran-approved-european-commission
5. Novartis. Novartis completes acquisition of The Medicines Company. https://www.novartis.com/news/media-releases/novartis-completes-acquisition-medicines-company
6. U.S. Food & Drug Administration. FDA approves new orphan drug for high cholesterol. https://www.fda.gov/drugs/postmarket-drug-safety-information-for-patients-and-providers/fda-drug-safety-communication-risk-of-allergic-reactions-certain-cholesterol-lowering-medicines-called-pcs9
7. U.S. Food & Drug Administration. FDA approves Leqvio to lower cholesterol. https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-leqvio-lower-cholesterol