Inclisiran (The Medicines Company/Alnylam Pharmaceuticals) is a systemically delivered siRNA therapeutic targeting mRNA for PCSK9. Inclisiran lowers both intracellular and extracellular PCSK9, though it is unclear whether that confers any advantages over monoclonal antibodies, which only impact extracellular PCSK9.
While inclisiran is somewhat late to the market relative to current PCSK9-inhibiting monoclonal antibodies, The Medicines Company hopes to disrupt the status quo with dosing every six months, along with price competition. The company also has initiated a cardiovascular outcomes trial that is designed to bolster its marketing by showing a numerically greater benefit on cardiovascular events than current PCSK9 inhibitors did in their studies, though this will just be due to trial design rather than a real advantage of the drug.
LIST OF FIGURES
7 Figure 1: Inclisiran Phase III efficacy
10 Figure 2: Datamonitor Healthcare’s drug assessment summary of inclisiran for dyslipidemia
11 Figure 3: Datamonitor Healthcare’s drug assessment summary of inclisiran for dyslipidemia
13 Figure 4: Inclisiran sales for dyslipidemia across the US, Japan, and five major EU markets, by country, 2018–27
LIST OF TABLES
6 Table 1: Inclisiran drug profile
7 Table 2: Inclisiran, change in LDL-C
8 Table 3: Clinical trials for inclisiran in dyslipidemia
9 Table 4: Inclisiran for dyslipidemia – SWOT analysis
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