The Medicines Company announced positive topline results for the ORION-9 Phase 3 clinical study in patients with Heterozygous Familial Hypercholesterolemia (HeFH). ORION-9 met all primary and secondary endpoints, and inclisiran demonstrated durable and potent efficacy and was well-tolerated with excellent safety that was generally well-balanced between the treatment groups. Furthermore, there were no treatment-related liver or renal laboratory abnormalities. FH is an inherited condition that causes high levels of LDL-C and leads to early onset of heart disease. Approximately one in 250 people in the world – 1.3 million people in the United States – have FH, but over 90% have not been properly diagnosed. HeFH is the most common form of FH. Homozygous FH (HoFH), the most severe form, is rarer and affects approximately 1 in 300,000 individuals worldwide. HoFH causes extremely high LDL-C resulting in aggressive heart disease at a very young age.