New Detailed Phase 3 Data Show Amgen's Novel Investigational Cholesterol-Lowering Medication Evolocumab Significantly Reduced LDL Cholesterol In Patients With A Rare And Serious Genetic Disorder That Causes High Cholesterol
THOUSAND OAKS, Calif., June 1, 2014 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced new detailed data from the Phase 3 TESLA study evaluating its novel investigational cholesterol-lowering medication, evolocumab (AMG 145), in patients with homozygous familial hypercholesterolemia (HoFH), a rare and serious genetic disorder characterized by extremely high low-density lipoprotein cholesterol (LDL-C), or "bad" cholesterol, and premature cardiovascular disease. 1 Phase 3 data from the TESLA study showed that adding evolocumab 420 mg subcutaneous monthly to a stable dose of statin therapy and other lipid-lowering medications significantly reduced LDL-C by 31 percent ( p<0.001) from baseline at week 12 compared to placebo. Results from the TESLA study, along with preliminary findings from the Phase 2/3 TAUSSIG study in patients with severe familial hypercholesterolemia (FH), were presented today in a Clinical & Late-Breaking Session at the 82 nd Congress of the European Atherosclerosis Society (EAS 2014).
Evolocumab is an 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. 2
"The data from the clinical studies evaluating evolocumab in patients with homozygous and severe familial hypercholesterolemia add to the growing body of clinical evidence supporting the effectiveness of our investigational cholesterol-lowering medication in multiple patient populations," said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. "We are extremely encouraged by these results and look forward to initiating global regulatory filings this year."
In the Phase 3 TESLA study in 49 HoFH patients, the most common adverse events (AEs), (more than one subject), in the evolocumab group were upper respiratory tract infection (three patients on evolocumab; one patient on placebo), influenza (three patients on evolocumab; 0 patients on placebo), gastroenteritis (two patients on evolocumab; 0 patients on placebo) and nasopharyngitis (two patients on evolocumab; 0 patients on placebo).
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