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|Amgen Presents Pooled Analysis Showing AMG 145 Significantly Reduced LDL Cholesterol In Over 1,200 Patients|
Elevated LDL-C is recognized as a major risk factor for cardiovascular (CV) disease.1,2 Despite the availability of various treatments to lower LDL-C, it is estimated that in two-thirds of treated, high-risk patients, LDL-C is not well-controlled.3,4
"Millions of people around the world are unable to control their LDL cholesterol with currently available treatment options," said
Results from the efficacy analysis showed mean reductions in LDL-C from baseline to week 12, as measured by preparative ultracentrifugation, ranged from 40 to 59 percent across AMG 145 doses in comparison to 0.1 to 0.5 percent for placebo (p=0.001). AMG 145 treatment was also associated with improvements in other lipid parameters, including high-density lipoprotein cholesterol (HDL-C), triglycerides, apolipoprotein B, lipoprotein(a) and apolipoprotein A1, within each targeted dose frequency of AMG 145.
In the safety analysis, adverse events (AEs) were observed more frequently with AMG 145 than placebo (57 percent vs. 49 percent) with the most frequent AEs being nasopharyngitis (8.3 percent vs. 7.5 percent) and upper respiratory tract infection (4.1 percent vs. 3.3 percent). Serious AEs were 2.0 percent with AMG 145 and 1.2 percent with placebo. The rates of injection-site reactions were similar between patients treated with AMG 145 and those treated with placebo (4.1 percent vs. 3.3 percent) while muscle-related AEs and anti-drug binding antibodies were 6.0 percent vs. 3.9 percent and 0.1 percent vs. 0.3 percent, respectively.
About the Pooled Analyses
– MENDEL (Monoclonal Antibody Against PCSK9 to Reduce Elevated LDL-C in Patients Currently Not Receiving Drug Therapy for Easing Lipid Levels) evaluated the efficacy, safety and tolerability of AMG 145 administered subcutaneously every two weeks and every four weeks in hyperlipidemic patients (LDL-C ³ 100 mg/dL and < 190 mg/dL) who were not receiving statin therapy.
– LAPLACE-TIMI 57 (LDL-C Assessment with P
– RUTHERFORD (RedUction of LDL-C With PCSK9 InhibiTion in HEteRozygous Familial HyperchOlesteRolemia Disorder Study) evaluated AMG 145 administered subcutaneously every month, in heterozygous familial hypercholesterolemic patients with an LDL-C >100 mg/dL who were on a stable dose of statin, with or without ezetimibe.
– GAUSS (Goal Achievement After Utilizing an anti-PCSK9 Antibody in Statin Intolerant Subjects) evaluated the efficacy, safety and tolerability of AMG 145 dosed subcutaneously every month, in hyperlipidemic patients who could not tolerate effective statin doses due to muscle-related side effects.
About AMG 145
About the AMG 145 Clinical Trial Program
The Phase 3 clinical trial program for AMG 145 builds upon the successful Phase 2 studies and includes 12 trials, with a combined planned enrollment of more than 27,000 patients. The Phase 3 studies will evaluate AMG 145 administered every two weeks and monthly in multiple patient populations, including in combination with statins in patients with hyperlipidemia (LAPLACE-2), in patients with hyperlipidemia who cannot tolerate statins (GAUSS-2), as a stand-alone treatment in patients with hyperlipidemia (MENDEL-2), and in patients whose elevated cholesterol is caused by genetic disorders called heterozygous (RUTHERFORD-2) and homozygous (TESLA and TAUSSIG) familial hypercholesterolemia.
Five studies of AMG 145 will provide long-term safety and efficacy data, including the FOURIER (Further Cardiovascular OUtcomes Research with PCSK9 Inhibition in
Additional information about clinical trials of AMG 145 can be found at www.clinicaltrials.gov.
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