Amgen announces positive top-line results from phase 3 GAUSS-3 trial of Repatha (evolocumab) – February 22, 2016

Amgen recently announced that the phase 3 GAUSS-3 (Goal Achievement After Utilizing an Anti-PCSK9 Antibody in Statin Intolerant Subjects-3) trial evaluating the efficacy of Repatha (evolocumab) met its co-primary endpoints of mean percent reductions from baseline in LDL-C at weeks 22 and 24 and the percent reduction from baseline LDL-C at week 24. No specific data was released but the press release noted that the results compared to ezetimibe were consistent with those observed in the phase 2 GAUSS-1 and phase 3 GAUSS-2 trials (which demonstrated a 38% mean reduction over ezetimibe). No new safety findings were identified in the GAUSS-3 trial and the most common adverse events were reported to be myalgia, nasopharyngitis, muscle spasms, arthralgia, pain in extremity, fatigue, headache, and back pain. In our eyes, these results are mostly anticipated and further confirm Repatha’s efficacy. Regarding any implications in diabetes, we are most looking forward to hearing Repatha’s first CV data, which continues to be expected in 2H16 – for more on the product’s latest, please see our coverage of Amgen 4Q15.