Phase III GAUSS-3 trial evaluating Repatha (evolocumab) meets endpoints in cholesterol reduction- Amgen

Amgen has announced that the Phase III 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 (LDL-C) at weeks 22 and 24, and the percent reduction from baseline in LDL-C at week 24. The mean percent reductions in LDL-C, or "bad" cholesterol, compared to ezetimibe, were consistent with results observed in the 12-week Phase II GAUSS-1 and Phase III GAUSS-2 trials.

In the GAUSS-3 trial there were no new safety findings. The most common adverse events that occurred in greater than 5 percent of patients in the Repatha group were myalgia, nasopharyngitis, muscle spasms, arthralgia, pain in extremity, fatigue, headache and back pain. The full data results from the Phase III GAUSS-3 trial will be submitted to a future medical conference and for publication.

Comment: GLAGOV, the intravascular ultrasound study, is underway to determine the effect of Repatha on coronary atherosclerosis in approximately 950 patients undergoing cardiac catheterization to test the hypothesis of robust LDL-C reduction leading to a reduction or a change in the build-up of plaque in the arteries. Results from the GLAGOV study are expected in the second half of 2016. In addition, the FOURIER outcomes trial is designed to evaluate whether treatment with Repatha in combination with statin therapy, reduces the risk of cardiovascular events in patients with high cholesterol and clinically evident cardiovascular disease. Top-line results are anticipated in the second half of 2016.