PARIS (dpa-AFX) - Regeneron Pharmaceuticals Inc. (REGN) and Sanofi 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 less than 0.0001) in both arms. Reductions were observed as early as week 4 and were maintained for the duration of therapy, until week 78.
Results of this analysis were presented today at the ESC Congress 2015 in London, and the 78 week results from two of the four trials included in the analysis, ODYSSEY FH I and II, were concurrently published online in the European Heart Journal.
Across the pooled analysis, the most common adverse events (occurring in at least five 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.
Across all primary and secondary endpoints assessed, there were statistical differences in favor of Praluent compared to placebo.1 Patients treated with Praluent achieved average LDL-C levels of less than 85 mg/dL at week 12, and maintained reductions through 78 weeks of therapy.
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