Sanofi and Regeneron Pharmaceuticals Inc announced that in a new pooled analysis of heterozygous familial hypercholesterolemia (HeFH) patients included in the ODYSSEY clinical trial program, Praluent® (alirocumab) significantly reduced bad cholesterol, known as low-density lipoprotein cholesterol (LDL-C). This analysis included 1,257 HeFH patients, the largest group of HeFH patients ever studied in a Phase 3 program. At week 24, when the primary efficacy endpoint was assessed, patients treated with Praluent had an average 56 percent greater reduction in LDL-C compared to placebo (p<0.0001) in both arms. Reductions were observed as early as week 4 and were maintained for the duration of therapy, until week 78.
Across the pooled analysis, the most common adverse events (occurring in at least 5 percent of patients in any Praluent group) were nasopharyngitis, injection site reaction, influenza, headache, upper respiratory tract infection, arthralgia, back pain, urinary tract infection, and myalgia.
People with HeFH have an inherited form of high cholesterol and are unable to process the body's natural supply of cholesterol in the liver, leading to very high levels of LDL-C that can block arteries (atherosclerosis) and can lead to a heart attack or stroke. If left untreated, people with HeFH typically have LDL-C levels of 200-400 milligrams/deciliter (mg/dL), are at high risk for premature atherosclerosis and cardiovascular (CV) events, and at 20 times greater risk of developing heart disease.
