Amgen announced that the phase 3 GAUSS-3 (Goal Achievement After Utilizing an Anti-PCSK9 Antibody in Statin Intolerant Subjects-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 2 GAUSS-1 and Phase 3 GAUSS-2 trials.

"The positive results from the GAUSS-3 study contribute to the growing body of evidence supporting Repatha as an innovative treatment option for patients who have not been able to adequately lower their LDL cholesterol through diet and statins alone," said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. "Many patients with high LDL cholesterol are unable to tolerate effective doses of statins, and the findings from the rigorously-designed GAUSS-3 study confirm the results in the previous GAUSS studies. We look forward to exploring these data further."

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 (PCSK9) inhibitor, in patients with high cholesterol who could not tolerate statins due to muscle-related side effects (MRSE). The active-controlled part of the trial evaluated the effect of 24 weeks of treatment with Repatha compared to ezetimibe on percent change from baseline in LDL-C.

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 3 GAUSS-3 trial will be submitted to a future medical conference and for publication.

Repatha (evolocumab) is a human monoclonal antibody that inhibits proprotein convertase subtilisin/kexin type 9 (PCSK9). Repatha binds to PCSK9 and inhibits circulating PCSK9 from binding to the low-density lipoprotein (LDL) receptor (LDLR), preventing PCSK9-mediated LDLR degradation and permitting LDLR to recycle back to the liver cell surface. By inhibiting the binding of PCSK9 to LDLR, Repatha increases the number of LDLRs available to clear LDL from the blood, thereby lowering LDL-C levels.

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.

The FOURIER outcomes trial is designed to evaluate whether treatment with Repatha in combination with statin therapy, compared to placebo plus statin therapy, reduces the risk of cardiovascular events in patients with high cholesterol and clinically evident cardiovascular disease, and completed patient enrollment in June 2015. Top-line results from the approximately 27,500-patient event-driven FOURIER study are anticipated in the second half of 2016.

Repatha is approved in the United States, Japan, Canada, Australia, Kuwait, and in all 28 countries that are members of the European Union as well as in Norway, Iceland and Liechtenstein. Applications in other countries are pending.

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