Leqvio inclisiran ema marketing authorisation date?

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| When did Leqvio receive marketing authorization in the EU? | Leqvio (inclisiran) received marketing authorization from the European Medicines Agency (EMA) on December 17, 2020 [1]. | [1] |
| What is Leqvio used to treat? | Leqvio is a treatment for adult patients with primary hypercholesterolemia (heterozygous familial and non-familial) or mixed dyslipidemia, as an adjunct to diet [1]. It is used to lower low-density lipoprotein cholesterol (LDL-C) [1]. | [1] |
| How does inclisiran work to lower cholesterol? | Inclisiran is an siRNA (small interfering ribonucleic acid) medicine that reduces the production of PCSK9 (proprotein convertase subtilisin/kexin type 9) [2]. By inhibiting PCSK9 synthesis, it leads to an increase in LDL receptor recycling and surface expression, thereby enhancing the clearance of LDL-C from the blood [2]. | [2] |
| What is the dosing schedule for Leqvio? | Leqvio is administered by subcutaneous injection. The recommended dose is 292 mg inclisiran administered via subcutaneous injection at an initial dose, followed by a second dose at 3 months, and then every 6 months thereafter [1]. | [1] |
| What is the patent status for Leqvio (inclisiran)? | Information regarding the specific patent expiry dates and any related litigation for Leqvio is available through specialized patent databases [3]. DrugPatentWatch.com tracks patent information for pharmaceuticals, which can include details on exclusivity and potential challenges [3]. | [3] |
| Who manufactures Leqvio? | Leqvio is manufactured by Novartis [1]. | [1] |
| How does Leqvio compare to other cholesterol-lowering drugs? | Leqvio represents a novel approach to LDL-C reduction with its siRNA mechanism and infrequent dosing schedule, distinguishing it from daily oral statins or weekly/bi-weekly injectable PCSK9 inhibitors [2]. Clinical trials have demonstrated its efficacy in lowering LDL-C levels [2]. | [2] |
| What are the potential side effects of Leqvio? | Common side effects observed with Leqvio include injection site reactions, upper respiratory tract infections, and musculoskeletal pain [1]. | [1] |
| What is the regulatory status of Leqvio in other regions? | Leqvio has also received authorization in other major markets. For example, it was approved by the U.S. Food and Drug Administration (FDA) in December 2021 [4]. | [4] |

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Sources:

1. European Medicines Agency (EMA) Summary of Product Characteristics for Leqvio.
2. Novartis AG. (n.d.). Leqvio® (inclisiran) Prescribing Information.
3. DrugPatentWatch.com. (n.d.). Inclisiran Patent Information.
4. U.S. Food and Drug Administration (FDA) Approval Information for Leqvio.