Amgen Reports Positive Top-Line Results From Phase 3 GAUSS-3 Trial Of Repatha

(RTTNews) - Amgen (AMGN) announced the Phase 3 GAUSS-3 trial evaluating Repatha (evolocumab) in patients with high cholesterol who cannot tolerate statins met its co-primary endpoints: mean percent reductions from baseline in low-density lipoprotein cholesterol at weeks 22 and 24, and the percent reduction from baseline in LDL-C at week 24. The company said the mean percent reductions in LDL-C, or bad cholesterol, compared to ezetimibe, were consistent with results observed in the 12-week Phase 2 GAUSS-1 and Phase 3 GAUSS-2 trials.

GAUSS-3 is a three-part trial that is evaluating the safety, tolerability and efficacy of Repatha, an injectable proprotein convertase subtilisin/kexin type 9 inhibitor, in patients with high cholesterol who could not tolerate statins due to muscle-related side effects.