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Amgen Inc announces positive top-line results from phase 3 TESLA Trial Of Evolocumab (AMG 145) in patients with Homozygous Familial Hypercholesterolemia

Monday, 17 Mar 2014 09:18am EDT 

Amgen Inc:Phase 3 TESLA trial evaluating evolocumab met its primary endpoint of percent reduction from baseline at week 12 in low-density lipoprotein cholesterol (LDL-C).Percent reduction in LDL-C, or bad cholesterol, was clinically meaningful and statistically significant.Evolocumab is investigational fully human monoclonal antibody that inhibits proprotein convertase subtilisin/kexin type 9 (PCSK9), a protein that reduces the liver's ability to remove LDL-C from the blood.1.TESLA was two-part Phase 2/3 trial evaluating evolocumab in patients with homozygous familial hypercholesterolemia (HoFH).Says rare and serious genetic disorder characterized by severely elevated LDL-C at an early age.Phase 3 TESLA trial evaluated safety, tolerability and efficacy of evolocumab compared to placebo in 49 adult and adolescent patients with HoFH who were on a stable dose of statin therapy and other lipid-lowering medication.Patients were randomized to evolocumab 420 mg subcutaneous monthly or placebo subcutaneous monthly.Safety was generally balanced across treatment groups.Most common adverse events in the evolocumab group (more than one subject) were upper respiratory tract infection, influenza, gastroenteritis and nasopharyngitis. 

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23 Jul 2014